Recall Z-1808-2019 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
Arrowg+ard Blue Advance" PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45041 VPS2
| Date | Apr 23, 2019 |
| Status | Terminated |
| Reason | Lidstock states the incorrect expiration date for the product |
| Root cause | Process control |
| Action | Arrow International initiated recall by letter dated April 23,2019 described the problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Complete the enclosed Acknowledgement Form indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. Distributors requested to subrecall. Questions, contact your local sale |
| Distribution | Nationwide Foreign: |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Feb 4, 2016 |