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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79197

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

Open FDA event record

Event summary

Timeline bucket
October 17, 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

12 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 12

Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018

Z-0647-2018
Recall number
Z-0647-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
5,926 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These finished good kits may contain the incorrect Springwire Guide (SWG).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information

Lot number: 23F16M0054

Distribution pattern

Distribution US Nationwide

device · product 2 of 12

Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018

Z-0648-2018
Recall number
Z-0648-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
5,926 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These finished good kits may contain the incorrect Springwire Guide (SWG).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information

Lot number: 13F16M0196

Distribution pattern

Distribution US Nationwide

device · product 3 of 12

Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018

Z-0649-2018
Recall number
Z-0649-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
5,926 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These finished good kits may contain the incorrect Springwire Guide (SWG).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information

Lot numbers: Product Code ASK-45703-PNHS: 23F16M0498 Product Code ASK-45703-PGMCL: 23F17A0505 Product Code ASK-45703-PNW: 23F17B0116

Distribution pattern

Distribution US Nationwide

device · product 4 of 12

Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018

Z-0650-2018
Recall number
Z-0650-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
5,926 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These finished good kits may contain the incorrect Springwire Guide (SWG).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information

Lot number: 23F17C0652

Distribution pattern

Distribution US Nationwide

device · product 5 of 12

Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK-15703-PRWJ; Exp. Dates Feb 2018- Nov 2018

Z-0651-2018
Recall number
Z-0651-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
5,926 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These finished good kits may contain the incorrect Springwire Guide (SWG).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information

Lot number: 13F17C0400

Distribution pattern

Distribution US Nationwide

device · product 6 of 12

Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dates Feb 2018 - Nov 2018

Z-0652-2018
Recall number
Z-0652-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
5,926 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These finished good kits may contain the incorrect Springwire Guide (SWG).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information

Lot number: 23F17C0757

Distribution pattern

Distribution US Nationwide

device · product 7 of 12

Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018

Z-0653-2018
Recall number
Z-0653-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
5,926 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These finished good kits may contain the incorrect Springwire Guide (SWG).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information

Lot number: 23F17D0182

Distribution pattern

Distribution US Nationwide

device · product 8 of 12

Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018

Z-0654-2018
Recall number
Z-0654-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
5,926 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These finished good kits may contain the incorrect Springwire Guide (SWG).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information

Lot number: 13F16M0241

Distribution pattern

Distribution US Nationwide

device · product 9 of 12

AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018

Z-0655-2018
Recall number
Z-0655-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
5,926 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These finished good kits may contain the incorrect Springwire Guide (SWG).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information

Lot numbers: Product Codes CDC-42703-XP1A: 23F16M0507 Product Code CDC-47702-XP1A: 23F17A0533

Distribution pattern

Distribution US Nationwide

device · product 10 of 12

ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018

Z-0656-2018
Recall number
Z-0656-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
5,926 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These finished good kits may contain the incorrect Springwire Guide (SWG).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information

Lot numbers: 13F17C0102 and 13F16M0264

Distribution pattern

Distribution US Nationwide

device · product 11 of 12

Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018

Z-0657-2018
Recall number
Z-0657-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
5,926 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These finished good kits may contain the incorrect Springwire Guide (SWG).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information

Lot number: 13F17C0501

Distribution pattern

Distribution US Nationwide

device · product 12 of 12

ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018

Z-0658-2018
Recall number
Z-0658-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
5,926 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These finished good kits may contain the incorrect Springwire Guide (SWG).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Code information

Lot numbers: Product Code AK-22142-CDC: 13F17A0021 13F17A0315 Product Code AK-22142-F: 13F17B0338 13F17E0067 Product Code AK-25142-CDC: 13F17E0340 Product Code AK-25142-F: 13F17A0207

Distribution pattern

Distribution US Nationwide