Recall Z-2269-2013 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Smiths Medical ASD, Inc.
Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medica
| Date | Sep 23, 2013 (initiated Sep 10, 2013) |
| Status | Terminated |
| Reason | Smiths Medical is conducting a voluntary recall of PORT-A-CATH and PORT-A-CATH II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports |
| Root cause | Mixed-up of materials/components |
| Action | Smiths Medical ASD, Inc. sent an Urgent Field Safety Notice dated September 6, 2013, to all affected customers. The letter described the problem and the product involved in the recall. The letter included the "Advice on Action to be Taken by the User" which instructed consignees to inspect and remove affected devices and to complete and return the "Urgent Field Safety Notice Confirmation Form. The letter also included information on the "Transmission of this Urgent Field safety Notice" which included information where customers should report issues related to the product to Smiths Medical's |
| Quantity | 372 |
| Distribution | Worldwide Distribution - USA including AZ, AR, CA, GA, IL, IN, KY, MD, MA, MI, NV, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WA, WV, WY. Internationally to DENMARK, BELGIUM CANADA. |
| FDA record | Open on fda.gov |