Recall Z-2331-2017 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term 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
| Date | May 9, 2017 |
| Status | Terminated |
| Reason | Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. |
| Root cause | Packaging |
| Action | Arrow International sent an Urgent Medical Device Recall Notification Letter dated May 11, 2017, to affected customers. The firm's notification letter is requesting that customers immediately assess their current inventory and to discontinue and quarantine any product with the specific lot codes listed in the letter. In addition, customers were asked to complete the Recall Acknowledgement form and fax or email it back to Customer Service so they can receive a Returns Good Authorization Number for the product's return. Customers with questions were instructed to contact their local sales re |
| Quantity | 27,485 units distributed in U.S., 4,371 units distributed internationally |
| Distribution | Worldwide Distribution - US (nationwide) and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112896 | ARRW EVOLUTION Arrow International (Subsidiary of Teleflex Inc.), May 10, 2012 |