Recall Z-0804-06 ยท MMP Cover, Barrier, Protective
Smiths Medical MD, Inc.
Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4683-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvente
| Date | Apr 27, 2006 (initiated Mar 29, 2006) |
| Status | Terminated |
| Reason | One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT systems. The packaged Wand-Cover is placed on the outside of the PORT-A-CATH II AND P.A.S. PORT tray. |
| Root cause | Other |
| Action | An Urgent Product Safety & Recall Notification, dated 03/29/06, was mailed to domestic customers and emailed to international customers. The letter described the issue, identified re-order number and lot numbers affected and gave 3 options. The options include to use only the sterile tray and discard the wand cover from the shelf box; remove and discard Locator-Wand Cover pouches and request replacement Locator-Wand Covers; or return the entire device for a credit or replacement. |
| Quantity | 506 trays |
| Distribution | Nationwide. AR, CA, DE, FL, IL, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OK, PA, TN, TX, VA, WI. Germany, Italy, Netherlands, Singapore, Spain |
| FDA record | Open on fda.gov |