Recall Z-2338-2017 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
| Date | May 9, 2017 |
| Status | Terminated |
| Reason | The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. |
| 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
| K061289 | ARROW PRESSURE INJECTABLE PICC Arrow International, Inc., Aug 24, 2006 |