Recall Z-1991-2021 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Bard Access Systems Inc.
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
| Date | May 19, 2021 |
| Status | Terminated |
| Reason | Catheter kits contained the incorrect micro-introducers. |
| Root cause | Process control |
| Action | On 05/19/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE RECALL" Notification via FedEx second day air to customer informing them that they have confirm through customer complaints that catheter kits contains the incorrect micro-introducers. Customer are instructed to: 1. Immediately review their inventory for the specific Catalog (Ref) and lot numbers and destroy all product subject to the recall following their institutions process for destruction. The Recalling Firm will replace discarded product. 2. Share this recall notification with all users within or outside their facility ne |
| Quantity | 180 units |
| Distribution | U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051672 | POWERPICC Bard Access Systems, Inc., Nov 23, 2005 |