Z-2268-2013 Class II Terminated
FDA device recall Z-2268-2013 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: 190.
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
- 190
Product Description
Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, 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
1991524 1997100 2033224 2051222 2116286 2183921 2192487 2210967 2229821 2237453
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2268-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026