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U.S. Department of Health and Human Services

Class 2 Device Recall PORTACATH and PORTACATH II implantable venous and arterial access systems

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 Class 2 Device Recall PORTACATH and PORTACATH II implantable venous and arterial access systems see related information
Date Posted September 23, 2013
Recall Status1 Terminated on October 21, 2014
Recall Number Z-2269-2013
Recall Event ID 66234
510(K)Number K932841  K932095  K955407 
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product 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.


Code Information 21-8011-24:

1971567
1979805
1984078
1997124
2006124
2038001
2090898
2151160
2196530
2216256
2249695

21-8052-24:

1971572
2012472
2022904
2067947
2080704
2146472
2168988
2196532
2207404
2237458
2249696
2269178
2282158

21-8053-24:

2168989
2249697
Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
651-633-2556
For Additional Information Contact
800-332-0178
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
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 Global Complaint Department at 1-866-216-8806 or globalcomplaints@smiths-medical.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 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.
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) Database 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.
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