Recall Z-1552-2021 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Bard Peripheral Vascular Inc
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
| Date | Mar 25, 2021 |
| Status | Terminated |
| Reason | Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. |
| Root cause | Process control |
| Action | On March 25,2021 Bard Peripheral Vascular distributed an "Urgent: Medical Device Recall notification to affected customers via FedEx and E-Mail. In addition to informing consignees about the recall, the firm ask customer to take the following actions: 1. Please check all inventory locations within your institution for the specific catalog and lot numbers of the PowerPort duo M.R.I. Implantable Ports listed above and immediately destroy all affected product remaining in your possession. 2. Share this notice with any users of the product within your facilities to ensure they are also aware of |
| Quantity | 287 units |
| Distribution | US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090512 | POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER C.R. Bard, Inc., Mar 27, 2009 |