| ||Class 2 Recall|
PORTACATH and PORTACATH II implantable venous and arterial access systems
||September 23, 2013
|Recall Event ID
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
||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 medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.
|Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul, Minnesota 55112-6929
|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
|COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
||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 Global Complaint Department at 1-866-216-8806 or email@example.com. For questions on the information provided they should contact 800-258-5361 (Smiths Medical's Customer Service Department).
For questions regarding this recall call 1-800-332-0178.
|Quantity in Commerce
||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.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = LJT and Original Applicant = PHARMACIA DELTEC, INC.
510(K)s with Product Code = LJT and Original Applicant = SIMS DELTEC, INC.