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Recall Observatory FDA recall evidence

Device product

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

Z-1705-2017

March 03, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 76637
Status
Terminated
Classification
Class II
Quantity
1,351 catheters
Official record key
device-enforcement:Z-1705-2017

Official wording

Reason: 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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling error