Z-2269-2013 Class II Terminated
FDA device recall Z-2269-2013 was initiated by Smiths Medical ASD, Inc. on Sep 10, 2013 and is designated Class II. 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… The recall status is terminated (terminated Oct 21, 2014). Affected quantity: 372.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 2, 2013
- Initiation Date
- Sep 10, 2013
- Termination Date
- Oct 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 372
Product Description
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.
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
Distribution Pattern
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2269-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026