Recall Z-0582-2020 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Bard Peripheral Vascular Inc
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
| Date | Feb 14, 2019 |
| Status | Open, Classified |
| Reason | Complaints received that products packaged with the incorrect introducer sheath size. |
| Root cause | Process control |
| Action | On 2/14/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" via FedEx informing them the firm has identified one product code/lot number (RECS2407) may be at risk of incorrectly containing a 6.5Fr introducer sheath instead of an 8Fr introducer sheath. Customer are instructed to: 1. Do not use or further distribute any affected product. 2. Check all inventory locations within their institution for affected product code / lot number combinations listed in the recall notice. If you have further distributed any of the product code / lot numbers, and to immediately contact that loc |
| Quantity | 900 units |
| Distribution | US - Nationwide OUS - None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063377 | POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER C.R. Bard, Inc., Jan 25, 2007 |