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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79890

76 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 11, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Arrow International Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

76 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 76

Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000

Z-1957-2018
Recall number
Z-1957-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17C0232 13F17G0194 13F17H0047 13F17J0083

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 2 of 76

Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N

Z-1958-2018
Recall number
Z-1958-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416, 055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17G0253 13F17A0200 13F17F0505 13F17G0256 13F17J0455 13F17C0193 13F17K0105 13F17C0198 13F17J0280 13F17A0063 13F17A0061 13F17B0252 13F17F0190 13F17L0701 13F17A0064 13F17C0225 13F17D0342 13F17J0229 13F17K0592 13F17M0002 13F17A0201 13F17D0246

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 3 of 76

Echogenic Introducer Needle; Product Code: AN-04318

Z-1959-2018
Recall number
Z-1959-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0231 13F17B0321 13F17C0241 13F17D0233 13F17E0301 13F17E0725 13F17F0603 13F17G0193 13F17J0089 13F17K0232 13F17L0230 13F17L0231 13F17L0232 13F17L0233

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 4 of 76

Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418

Z-1960-2018
Recall number
Z-1960-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product code AN-04320: 13F17A0131,13F17B0101,13F17B0320,13F17D0234, 13F17F0242,13F17H0488,13F17J0454,13F17M0003 Product code AN-04418: 13F17F0738 and 13F17J0445

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 5 of 76

Epidural Needle; Product Codes: AN-05501 and AN-05505

Z-1961-2018
Recall number
Z-1961-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product code AN-05501: 13F17A0211 13F17B0082 13F17C0378 13F17D0082 13F17E0023 13F17E0329 13F17E0838 13F17F0432 13F17F0813 13F17G0333 13F17H0059 13F17J0002 13F17L0598 Product code AN-05505: 13F17A0213 13F17C0109 13F17C0479 13F17E0208 13F17F0254 13F17F0727 13F17G0357 13F17J0161 13F17J0274 13F17L0441

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 6 of 76

SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500

Z-1962-2018
Recall number
Z-1962-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0065 13F17B0190 13F17D0264 13F17F0246 13F17F0653 13F17J0082 13F17K0412

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 7 of 76

Maximal Barrier Drape; Product Codes: ASK-00001-1A

Z-1963-2018
Recall number
Z-1963-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17E0104 13F17F0318 13F17G0569 13F17J0423 13F17L0130

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 8 of 76

Maximal Barrier Drape; Product Codes: ASK-00002-1A

Z-1964-2018
Recall number
Z-1964-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0212 13F17D0025 13F17D0154 13F17E0193 13F17F0352 13F17G0102 13F17G0102 13F17G0347 13F17H0347 13F17K0324 13F17K0377 13F17L0462

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 9 of 76

Maximal Barrier Drape; Product Codes: ASK-00376-SU

Z-1965-2018
Recall number
Z-1965-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0089 13F17L0152

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 10 of 76

Maximal Barrier Drape; Product Code: ASK-01000-UPMS

Z-1966-2018
Recall number
Z-1966-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0280 13F17H0434 13F17L0480

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 11 of 76

Maximal Barrier Drape; Product Code: ASK-04000-HMC

Z-1967-2018
Recall number
Z-1967-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0216 13F17D0073 13F17F0163 13F17G0522 13F17H0487 13F17L0121 13F17L0651

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 12 of 76

Radial Arterial Access Kit; Product Code: ASK-04001-BID2

Z-1968-2018
Recall number
Z-1968-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0195 13F17D0213 13F17F0428 13F17K0314 13F17L0113

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 13 of 76

Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1

Z-1969-2018
Recall number
Z-1969-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17E0562 13F17G0537 13F17K0188 13F17L0167

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 14 of 76

Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1

Z-1970-2018
Recall number
Z-1970-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product code ASK-04020-AH: 13F17B0102 13F17C0283 13F17F0221 13F17G0480 13F17J0045 13F17L0127 Product code ASK-04020-MIHS: 13F17A0174 13F17F0139 Product code ASK-04120-HF1: 13F17C0360 13F17D0034 13F17E0093 13F17F0468 13F17G0269 13F17J0101 13F17K0311 13F17L0489

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 15 of 76

Arterial Catheterization Kit; Product Codes: ASK-04020-DH

Z-1971-2018
Recall number
Z-1971-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0307 13F17D0070 13F17E0417 13F17G0012 13F17G0508 13F17H0421 13F17L0155 13F17L0478

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 16 of 76

Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM

Z-1972-2018
Recall number
Z-1972-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17C0179 13F17E0655 13F17G0301 13F17H0284 13F17K0566 13F17M0019

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 17 of 76

Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF

Z-1973-2018
Recall number
Z-1973-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17C0281 13F17G0398

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 18 of 76

Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ

Z-1974-2018
Recall number
Z-1974-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17E0674 13F17G0265 13F17J0087 13F17K0099 13F17L0250

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 19 of 76

Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM

Z-1975-2018
Recall number
Z-1975-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0258 13F17D0075 13F17G0275 13F17L0615

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 20 of 76

Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA

Z-1976-2018
Recall number
Z-1976-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17E0762 13F17F0599 13F17H0058 13F17J0241 13F17L0114 13F17L0485

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 21 of 76

Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB

Z-1977-2018
Recall number
Z-1977-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17D0180 13F17H0192 13F17K0223 13F17K0555

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 22 of 76

Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP

Z-1978-2018
Recall number
Z-1978-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17C0183 13F17F0775

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 23 of 76

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1

Z-1979-2018
Recall number
Z-1979-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0389 13F17E0430 13F17F0580 13F17H0545 13F17K0403 13F17L0285

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 24 of 76

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC

Z-1980-2018
Recall number
Z-1980-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0285 13F17C0381 13F17D0214 13F17E0356 13F17F0736 13F17H0483

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 25 of 76

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP

Z-1981-2018
Recall number
Z-1981-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: ASK-15703-PVH: 13F17D0024 13F17E0454 13F17G0083 13F17H0048 13F17J0096 13F17K0195 13F17L0138 13F17L0679 ASK-15703-PNYP: 13F17H0123

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 26 of 76

ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2

Z-1982-2018
Recall number
Z-1982-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17E0597 13F17F0395 13F17K0120 13F17L0532

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 27 of 76

MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR

Z-1983-2018
Recall number
Z-1983-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product code ASK-21242-NYP: 13F17A0076 13F17B0076 13F17B0225 13F17E0773 13F17H0129 13F17J0020 13F17J0395 13F17L0012 Product code ASK-21242-PR: 13F17B0260 13F17F0591 13F17L0010 13F17L0273 13F17M0136

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 28 of 76

Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC

Z-1984-2018
Recall number
Z-1984-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17D0267 13F17F0310 13F17H0326 13F17K0315

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 29 of 76

ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2

Z-1985-2018
Recall number
Z-1985-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0024 13F17E0019 13F17E0673 13F17J0236 13F17L0497 13F17E0019 13F17E0673 13F17J0236 13F17L0497

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 30 of 76

Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Product Codes: ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1

Z-1986-2018
Recall number
Z-1986-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Codes ASK-29803-SJH: 13F17A0276 13F17D0104 13F17F0165 13F17G0452 13F17H0251 13F17K0284 13F17L0363 Product code ASK-29903-SJH: 13F17C0105 13F17E0803 13F17G0422 13F17H0161 13F17H0204 13F17K0193 13F17M0197 Product code ASK-29903-UW1: 13F16L0231 13F17F0691

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 31 of 76

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1

Z-1987-2018
Recall number
Z-1987-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Codes ASK-42703-MHW: 13F16M0282 13F17D0183 13F17H0260 13F17M0344 Product Code ASK-42703-OLL1: 13F17C0293 13F17E0414 13F17J0243

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 32 of 76

Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1

Z-1988-2018
Recall number
Z-1988-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Code ASK-42703-PAM1: 13F17K0077 13F17L0494 Product code ASK-42703-PSHR1: 13F17C0361 13F17F0207 13F17H0518 13F17M0278 Product code ASK-45703-PNY: 13F17H0124 13F17H0451 Product code ASK-45703-PWHC1: 13F17E0022

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 33 of 76

ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A

Z-1989-2018
Recall number
Z-1989-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot numbers: Product code CDC-42854-P1A: 13F17C0137 13F17E0177 13F17E0598 13F17F0644 13F17G0287 13F17H0118 13F17K0156 13F17L0017 13F17M0158 Product code CDC-45854-P1A: 13F17C0396 13F17C0439 13F17D0062 13F17D0284 13F17E0618 13F17F0126 13F17G0293 13F17H0263 13F17J0055 13F17K0168 13F17L0021 13F17L0353 13F17L0590

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 34 of 76

Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW

Z-1990-2018
Recall number
Z-1990-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17E0141 13F17E0300 13F17H0147 13F17J0336

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 35 of 76

Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM and ASK-42854-PRR

Z-1991-2018
Recall number
Z-1991-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Code ASK-45854-PSFM: 13F17C0072 13F17E0166 13F17H0261 13F17J0339 13F17L0020 13F17L0401 Product Code ASK-42854-PRR: 13F17B0034 13F17B0278 13F17E0800 13F17H0142 13F17K0160

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 36 of 76

ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A

Z-1992-2018
Recall number
Z-1992-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0333 13F17C0338 13F17D0322 13F17E0539 13F17E0870 13F17F0116 13F17H0136 13F17J0024 13F17K0268 13F17L0062 13F17L0207 13F17L0397

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 37 of 76

Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1

Z-1993-2018
Recall number
Z-1993-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17D0321 13F17H0137 13F17L0063 13F17L0555

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 38 of 76

ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A

Z-1994-2018
Recall number
Z-1994-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Code CDC-45703-P1A: 13F17J0061 13F17J0084 13F17J0451 13F17K0249 13F17K0250 13F17K0383 13F17K0575 13F17L0576 13F17M0154 Product code CDC-45703-PB1A: 13F17B0350 13F17E0048 13F17E0719 13F17H0308 13F17L0099 Product code CDC-42703-P1A: 13F16M0232 13F17J0065 13F17J0450 13F17K0069 13F17K0136 13F17K0288 13F17K0419 13F17K0567 13F17L0223 13F17L0573 Product code CDC-15703-P1A: 13F17A0025 13F17E0279 13F17E0457 13F17F0160 13F17F0769 13F17G0349 13F17J0133 13F17J0134 13F17L0103 13F17M0200

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 39 of 76

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip¿, ARROWg+ard Blue PLUS¿ Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LDP1, ASK-45703-PBHS, ASK-45703-PHMC

Z-1995-2018
Recall number
Z-1995-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Codes ASK-45703-LDP1: 13F17G0033 Product code ASK-45703-PBHS: 13F16M0260 13F17C0150 13F17E0406 13F17G0421 13F17H0420 13F17L0522 Product code ASK-45703-PHMC: 13F17A0047 13F17B0011 13F17H0012 13F17L0421

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 40 of 76

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-PHCH

Z-1996-2018
Recall number
Z-1996-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0408 13F17E0421 13F17L0288

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 41 of 76

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH

Z-1997-2018
Recall number
Z-1997-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Code ASK-42703-PTJH: 13F17A0168 13F17C0074 13F17D0339 13F17G0029 13F17G0453 13F17L0509 Product code ASK-45703-PTJH: 13F17B0016 13F17C0089 13F17D0105 13F17F0062 13F17H0250 13F17K0220 13F17L0560

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 42 of 76

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1

Z-1998-2018
Recall number
Z-1998-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0020 13F17B0269 13F17C0303 13F17F0317 13F17H0062 13F17J0386 13F17K0583 13F17L0455

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 43 of 76

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1

Z-1999-2018
Recall number
Z-1999-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0020 13F17B0269 13F17C0303 13F17F0317 13F17H0062 13F17J0386 13F17K0583 13F17L0455

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 44 of 76

ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH

Z-2000-2018
Recall number
Z-2000-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17E0547 13F17F0680 13F17G0214 13F17J0347 13F17L0150

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 45 of 76

Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC

Z-2001-2018
Recall number
Z-2001-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Code ASK-42802-VC: 13F17B0388 13F17E0134 13F17H0132 13F17K0152 Product code ASK-47702-VC: 13F17E0669 13F17H0311 13F17L0076

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 46 of 76

Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC

Z-2002-2018
Recall number
Z-2002-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17C0063 13F17F0665 13F17H0388

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 47 of 76

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH

Z-2003-2018
Recall number
Z-2003-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17E0712 13F17H0264 13F17K0086 13F17K0547 13F17L0647

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 48 of 76

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-45703-SCH; ASK-45703-UAB, ASK-45703-VAH

Z-2004-2018
Recall number
Z-2004-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Code ASK-45703-SCH: 13F17B0193 13F17E0461 13F17G0450 Product Code ASK-45703-UAB: 13F17C0210 Product Code ASK-45703-VAH: 13F16M0294 13F17E0398 13F17H0074

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 49 of 76

ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC

Z-2005-2018
Recall number
Z-2005-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0219 13F17C0013 13F17C0431 13F17D0166 13F17F0070 13F17F0714 13F17G0590 13F17J0392 13F17L0070

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 50 of 76

4Fr. Catheter Clamp with Fastener; Product Code: CC-00004

Z-2006-2018
Recall number
Z-2006-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0199 13F17C0048 13F17D0270 13F17F0258 13F17G0529

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 51 of 76

5Fr. Catheter Clamp with Fastener; Product Code: CC-00005

Z-2007-2018
Recall number
Z-2007-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0198 13F17C0056 13F17D0135 13F17D0236 13F17F0075 13F17F0600 13F17G0179 13F17H0107 13F17H0367 13F17J0198 13F17K0212

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 52 of 76

7Fr. Catheter Clamp with Fastener; Product Code: CC-00007

Z-2008-2018
Recall number
Z-2008-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0257 13F17D0260 13F17E0342 13F17F0076 13F17F0795 13F17J0271

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 53 of 76

8Fr. Catheter Clamp with Fastener; Product Code: CC-00008

Z-2009-2018
Recall number
Z-2009-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0050 13F17D0271 13F17F0078 13F17J0276

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 54 of 76

Clear Fenestrated Drape with Adhesive; Product Code: CD-00001

Z-2010-2018
Recall number
Z-2010-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17G0258 13F17J0281

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 55 of 76

Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018

Z-2011-2018
Recall number
Z-2011-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0039 13F17C0181 13F17D0226 13F17E0065 13F17E0724 13F17F0651 13F17G0531 13F17H0377 13F17J0273 13F17L0216 13F17L0218

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 56 of 76

TheraCath(R) Epidural Catheter; Product Code: EC-05000

Z-2012-2018
Recall number
Z-2012-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0147 13F17C0176 13F17C0419 13F17E0464 13F17F0039 13F17F0498 13F17F0609 13F17F0789 13F17G0250 13F17J0076 13F17K0413 13F17K0414 13F17K0415 13F17K0416

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 57 of 76

0.2 Micron Flat Epidural Filter; Product Code: EF-05500

Z-2013-2018
Recall number
Z-2013-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17D0240 13F17G0371 13F17K0408

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 58 of 76

Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900

Z-2014-2018
Recall number
Z-2014-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17C0326 13F17E0123 13F17F0584 13F17G0519 13F17H0292

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 59 of 76

ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM

Z-2015-2018
Recall number
Z-2015-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product code JR-42063-HPHNM: 13F17C0327 Product code JR-42563-HPHNM: 13F17F0099

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 60 of 76

10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501

Z-2016-2018
Recall number
Z-2016-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17C0328 13F17F0296 13F17G0202 13F17H0104 13F17J0207

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 61 of 76

Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS

Z-2017-2018
Recall number
Z-2017-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Code MSO-29802-AHS: 13F17C0408 13F17E0419 13F17F0683 13F17H0283 13F17K0545 Product Code MSO-29903-AHS: 13F17E0607 13F17G0356 13F17K0327 13F17L0350

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 62 of 76

ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Code: MSO-45703-AHS

Z-2018-2018
Recall number
Z-2018-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17C0230 13F17D0161 13F17F0068 13F17G0364 13F17H0351 13F17J0387 13F17K0579 13F17L0487

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 63 of 76

Arterial Catheterization Kit; Product Code:NA-04550-1A

Z-2019-2018
Recall number
Z-2019-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0315 13F17C0033 13F17C0462 13F17F0145 13F17F0550 13F17G0229 13F17H0049 13F17H0328

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 64 of 76

PICC Catheter Trimmer ; Product Code:PC-00001-T

Z-2020-2018
Recall number
Z-2020-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17C0349 13F17F0300

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 65 of 76

Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052

Z-2021-2018
Recall number
Z-2021-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Code: PL-05041 13F17G0050 13F17J0360 13F17K0376 Product Code and PL-05052: 13F17C0435 13F17E0720 13F17G0077 13F17G0514

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 66 of 76

Echogenic Needle; Product codes: PN-00215-E and PN-00217-E

Z-2022-2018
Recall number
Z-2022-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Codes PN-00215-E: 13F17J0072 13F17K0211 13F17L0700 Product code PN-00217-E: 13F17C0329 13F17E0118 13F17F0503 13F17G0093 13F17G0534 13F17H0383 13F17L0234

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 67 of 76

ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM

Z-2023-2018
Recall number
Z-2023-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Code PR-34052-HPHNM: 13F17C0351 Product Code PR-34063-HPHNM: 13F17F0192 Product Code PR-35041-HPHNM: 13F17B0290 13F17C0231 13F17D0238 13F17F0276 13F17F0577 13F17H0365 13F17J0409 13F17K0490 13F17L0394 13F17L0395 Product Code PR-35052-HPHNM: 13F17B0092 13F17B0256 13F17C0043 13F17D0094 13F17D0239 13F17E0224 13F17F0586 13F17H0354 13F17J0196 13F17K0549 13F17L0474 13F17L0697 13F17M0121 Product Code PR-35541-HPHNL: 13F17F0219 13F17H0523 Product Code PR-35541-HPHNM: 13F17A0110 13F17B0046 13F17B0161 13F17C0353 13F17F0652 Product Code PR-35552-HPHNL: 13F17B0322 13F17J0008 Product Code PR-35552-HPHNM: 13F17B0109 13F17B0318 13F17F0245

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 68 of 76

ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM

Z-2024-2018
Recall number
Z-2024-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product Code PR-35563-HPHNL: 13F17F0445 Product Code PR-35563-HPHNM: 13F17K0495

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 69 of 76

Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM

Z-2025-2018
Recall number
Z-2025-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: Product code: PR-44041-BAS: 13F17F0101 PR-44052-BAS: 13F17F0103 13F17K0128 PR-44063-BAS: 13F17F0104 13F17K0129 PR-45041-BAS: 13F17F0105 13F17K0241 PR-45052-BAS: 13F17F0106 13F17K0236 PR-45063-BAS: 13F17J0203 13F17K0471 PR-45541-BAS: 13F17F0107 PR-45541-HPHNL: 13F17A0165 13F17D0327 13F17G0008 13F17H0416 13F17H0572 13F17K0238 13F17L0049 PR-45541-HPHNM: 13F17B0174 13F17C0188 13F17E0738 13F17G0006 PR-45552-BAS: 13F17F0108 13F17K0237 PR-45552-HPHNL: 13F17C0467 13F17E0017 13F17E0758 13F17F0523 PR-45552-HPHNM: 13F17B0178 13F17C0469 13F17E0120 13F17G0412 13F17H0393 13F17J0172 13F17L0335 PR-45563-BAS: 13F17F0109 PR-45563-HPHNL: 13F17C0354 13F17D0341 13F17J0402 PR-45563-HPHNM: 13F17L0688

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 70 of 76

VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ

Z-2026-2018
Recall number
Z-2026-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0120 13F17A0287 13F17C0018 13F17D0136 13F17E0122

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 71 of 76

VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO

Z-2027-2018
Recall number
Z-2027-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0288

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 72 of 76

VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP

Z-2028-2018
Recall number
Z-2028-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0119 13F17D0019 13F17D0130 13F17D0186 13F17D0278 13F17E0113 13F17F0193 13F17F0480 13F17G0074 13F17G0329 13F17G0506 13F17H0536 13F17J0208 13F17K0438

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 73 of 76

Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847

Z-2029-2018
Recall number
Z-2029-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17B0051 13F17E0713 13F17F0767 13F17J0010

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 74 of 76

Extension Line Slide Clamps; Product codes: SA-09847

Z-2030-2018
Recall number
Z-2030-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17A0109 13F17D0071 13F17E0795 13F17F0743 13F17H0099 13F17K0227

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 75 of 76

ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1

Z-2031-2018
Recall number
Z-2031-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17C0004 13F17G0030

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

device · product 76 of 76

9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-09903-S

Z-2032-2018
Recall number
Z-2032-2018
Initiated
April 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
416,055 total products

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed packaging
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility may be compromised due to unsealed packaging.

Code information

Lot Numbers: 13F17H0405

Distribution pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM