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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74898

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

Open FDA event record

Event summary

Timeline bucket
February 17, 2016
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

4 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 4

Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components

Z-2771-2016
Recall number
Z-2771-2016
Initiated
February 17, 2016
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
6,121 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

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

Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

Code information

Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285

Distribution pattern

US Distribution to states of: NC, OH, FL, and MD.

device · product 2 of 4

Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

Z-2772-2016
Recall number
Z-2772-2016
Initiated
February 17, 2016
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
6,121 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

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

Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

Code information

Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285

Distribution pattern

US Distribution to states of: NC, OH, FL, and MD.

device · product 3 of 4

Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.

Z-2773-2016
Recall number
Z-2773-2016
Initiated
February 17, 2016
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
6,121 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

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

Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

Code information

Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285

Distribution pattern

US Distribution to states of: NC, OH, FL, and MD.

device · product 4 of 4

Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.

Z-2774-2016
Recall number
Z-2774-2016
Initiated
February 17, 2016
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
6,121 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

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

Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

Code information

Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285

Distribution pattern

US Distribution to states of: NC, OH, FL, and MD.