Recall Z-2268-2013— Smiths Medical ASD, Inc.

Name: FDA recall Z-2268-2013
Creator: U.S. Food and Drug Administration
Published: 2013-09-10

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2013-09-10, terminated 2014-10-21. It names one FDA 510(k) clearance: K871132. Product: 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: 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.

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-09-10
Terminated: 2014-10-21
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K871132 — PHARMACIA DELTEC SUBCLAVIAN INTRODUCERSDeltec Systems, Inc.·cleared 1987-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.