Smiths Medical ASD, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2268-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 10, 2013

Date Posted: October 2, 2013

Recall Number: Z-2268-2013

Event ID: 66234

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

Status: Terminated

Product Quantity: 190

Code Information:

1991524 1997100 2033224 2051222 2116286 2183921 2192487 2210967 2229821 2237453

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.

Voluntary or Mandated:

Voluntary: Firm initiated