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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76637

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 03, 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

1 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 1

The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.

Z-1705-2017
Recall number
Z-1705-2017
Initiated
March 03, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
1,351 catheters

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling error

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

Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.

Code information

Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844

Distribution pattern

US Distribution