Medical device recalls Moderate risk

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

Recall date
March 3, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1705-2017
FDA classification
Class II
Brand / firm
Arrow International Inc
Sold / distributed
US Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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