Z-1705-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2017
- Initiation Date
- March 3, 2017
- Termination Date
- February 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,351 catheters
Product Description
The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
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.
Distribution Pattern
US Distribution
Code Information
Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844