FDA Device recall Z-2268-2013
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 imp…
- FDA Device
- Class II
- terminated
- Published 2013-10-02
On 2013-10-02 the FDA classified a Class II recall of 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 imp… by Smiths Medical Asd, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2268-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-10 |
| Published | 2013-10-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smiths Medical Asd |
| Distribution | AR, AZ, CA, GA, IL, IN, KY, MA, MD, MI, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, WV, WY |
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
Identifiers
| code_info | 1991524 1997100 2033224 2051222 2116286 2183921 2192487 2210967 2229821 2237453 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2268-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.