Recall Z-1578-2020 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Bard Peripheral Vascular Inc
1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system.
| Date | Oct 1, 2019 |
| Status | Terminated |
| Reason | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation. |
| Root cause | Component change control |
| Action | On October 1, 2019, Bard sent a "Urgent Medical Device REcall Notification" letter to all customers via FedEx. The recall notification informed customer about the reason for the recall. In addition, to informing customers about the recall, the letter asked that customers take the following actions: 1. Our records show that your facility has purchased product codes affected by this voluntary recall. Do not use or further distribute any affected product. 2. Please check all inventory locations within your institution for affected product code / lot number combinations listed in the recall not |
| Quantity | 225 Catheters |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,VA, VT, WA, WI, WV, WY and countries of Brazil, Canada, EMEA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022983 | BARDPORT X-PORT ISP PORT C.R. Bard, Inc., Sep 25, 2002 |