Recall Z-1525-2010 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Bard Access Systems
PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico Indicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals.
| Date | Apr 29, 2010 (initiated Mar 18, 2010) |
| Status | Terminated |
| Reason | 8F PowerPort stems were mixed with 6F PowerPorts and packaged. |
| Root cause | Mixed-up of materials/components |
| Action | The firm, Bard Access Systems, Inc. (BAS) sent a "URGENT: Powerport isp M.R.I with 6F Chronoflex Catheter RECALL" letter dated March 18, 2010, to the customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to immediately examine their inventory and quarantine all products subject to this recall and notify any customers they may have distributed the product to; DO NOT USE THIS PRODUCT OR FURTHER DISTRIBUTE ANY OF THE IMPLICATED LOTS; remove and return the affected lots to BAS, and complete and Fax the Reply Form and Inventory Re |
| Quantity | 200 units total (100 units of each lot, see code information) |
| Distribution | Nationwide distribution: AZ, CA, DC, FL, MA, MD, NC, NE, NV, NY, PA and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072549 | TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER C.R. Bard, Inc., Nov 14, 2007 |