Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
- Company
- Arrow International Inc
- Recall Initiated
- January 6, 2021
- Terminated
- July 12, 2022
- Recall Number
- Z-1106-2021
- Quantity
- 1,705 eaches
- Firm Location
- Reading, PA
Reason for Recall
The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine or sulfa could result in an allergic reaction
Distribution
US Nationwide
Lot / Code Info
Lot Code: 13F20E0173
Root Cause
Under Investigation by firm
Action Taken
Arrow International issued Urgent Medical Device Correction notification letter on 6th Jan 2021 via FedEx 2-day mail.Letter states reason for recall, health risk and action to take: 1. If you have affected stock in inventory, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected products within your control to confirm the product code on the lidstock matches the product code on the banner card of the same kit. Products confirmed to have an incorrect banner card should be returned to Arrow International. Products which properly match should not be returned. 3. If you have product with an incorrect banner card, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. 4. If you have no affected stock, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.