Recall Z-1365-2019 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equi
| Date | Dec 13, 2018 |
| Status | Terminated |
| Reason | Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC |
| Root cause | Employee error |
| Action | Arrow International initiated recall notification letter on 13th December 2018 via FedEx 2-day mail describing problem ,health risk and action to take:, immediately discontinue use and quarantine the products. Complete the enclosed Acknowledgement Form as soon as possible 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. |
| Quantity | 963 units (US) in total |
| Distribution | US Nationwide Distribution |
| 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 |