Recall Z-0602-2018 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
| Date | Jul 25, 2017 |
| Status | Terminated |
| Reason | Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained. |
| Root cause | Packaging process control |
| Action | Arrow International notified all U.S. consignees with letter sent on July 25, 2017, via FedEx 2-day. second notification August 22, 2017, third notification November 28, 2017. |
| Quantity | 2691 total |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113277 | ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS Arrow International, Inc., Jun 21, 2012 |