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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79314

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

Open FDA event record

Event summary

Timeline bucket
October 26, 2017
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

7 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 7

Radial Artery Catheterization Kit; Model: AK-04018

Z-1281-2018
Recall number
Z-1281-2018
Initiated
October 26, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
930

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Code information

Lots: 13F16H0183, 13F17E0728, 13F17F0525, 23F16E1188, 23F16H0911; Expiration dates: October 2018 through March 2020

Distribution pattern

US nationwide distribution, including Puerto Rico.

device · product 2 of 7

Radial Artery Catheterization Kit; Model: AK-04020

Z-1282-2018
Recall number
Z-1282-2018
Initiated
October 26, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
50,263

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Code information

Lots: 13F16H0263, 13F16J0335, 13F16K0145, 13F16M0246, 13F17C0500, 13F17F0199, 13F17F0473, 13F17F0530, 13F17G0325, 23F16E1189, 23F16E1190, 23F16F0474, 23F16F1041, 23F16H0164; Expiration dates: October 2018 through March 2020

Distribution pattern

US nationwide distribution, including Puerto Rico.

device · product 3 of 7

Radial Artery Catheterization Kit; Model: AK-04020-C

Z-1283-2018
Recall number
Z-1283-2018
Initiated
October 26, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
24,192

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Code information

Lots: 13F16H0430, 13F16M0224, 13F16M0242, 13F17F0150, 13F17F0475, 13F17G0240, 23F16E1193, 23F16F0476, 23F16G0085, 23F16H0013, 23F16H0680; Expiration dates: October 2018 through March 2020

Distribution pattern

US nationwide distribution, including Puerto Rico.

device · product 4 of 7

Radial Artery Catheterization Kit; Model: AK-04120

Z-1284-2018
Recall number
Z-1284-2018
Initiated
October 26, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
2491

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Code information

Lots: 13F16H0289, 13F16M0161, 13F17E0858, 13F17G0178, 23F16E1191, 23F16H0163; Expiration dates: October 2018 through March 2020

Distribution pattern

US nationwide distribution, including Puerto Rico.

device · product 5 of 7

Radial Artery Catheterization Kit; Model: AK-04122

Z-1285-2018
Recall number
Z-1285-2018
Initiated
October 26, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
570

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Code information

Lots: 13F16H0329, 13F17F0074, 13F17G0237; Expiration dates: October 2018 through March 2020

Distribution pattern

US nationwide distribution, including Puerto Rico.

device · product 6 of 7

Radial Artery Catheterization Kit; Model: AK-04220

Z-1286-2018
Recall number
Z-1286-2018
Initiated
October 26, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
6358

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Code information

Lots: 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, 23F16J0018; Expiration dates: October 2018 through March 2020

Distribution pattern

US nationwide distribution, including Puerto Rico.

device · product 7 of 7

Arterial Access Tray, introducer catheter; Model: GU-04020

Z-1287-2018
Recall number
Z-1287-2018
Initiated
October 26, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
1190

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Code information

Lots: 13F17A0292, 13F17C0309, 13F17E0359, 13F17G0300, 13F17J0242, 23F16F0623, 23F16G0675; Expiration dates: October 2018 through March 2020

Distribution pattern

US nationwide distribution, including Puerto Rico.