Recall Z-1994-2021 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Bard Access Systems Inc.
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
| Date | May 19, 2021 |
| Status | Terminated |
| Reason | Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire. |
| Root cause | Process control |
| Action | On 05/19/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE CORRECTION" Notification via FedEx 2-day to customers informing them that the Recalling Firm has confirmed through customer complaint that a number of catheter convenience kits labeled as having 70cm guidewires may actually contain 50cm guidewires. The Recalling Firm is providing customers with a quick way of identifying if their kit contains the correct or incorrect size guidewire by determining the number of loops of the wire. Customers are instructed to: 1. Immediately review their inventory for the specific Catalog (Ref) an |
| Quantity | 30 kits |
| Distribution | U.S. Nationwide distribution in the state of RI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.