Z-2268-2013Class II

Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only...

Name: Z-2268-2013 Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only...
Creator: Smiths Medical ASD, Inc.
Published: 2013-09-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-09-10 / Terminated

FDA source

Smiths Medical ASD, Inc. began a 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 implantable venous and... on 2013-09-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2268-2013
Classification: Class II
Status: Terminated
Initiated: 2013-09-10
Posted: 2013-09-23
Terminated: 2014-10-21
Recalling firm: Abbott Medical
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.
Product code: DYB Introducer, Catheter
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
FDA root cause: Mixed-up of materials/components
Action: Smiths Medical ASD, Inc. sent an Urgent Field Safety Notice dated September 6, 2013, to all affected customers. The letter described the problem and the product involved in the recall. The letter included the "Advice on Action to be Taken by the User" which instructed consignees to inspect and remove affected devices and to complete and return the "Urgent Field Safety Notice Confirmation Form. The letter also included information on the "Transmission of this Urgent Field safety Notice" which included information where customers should report issues related to the product to Smiths Medical's Global Complaint Department at 1-866-216-8806 or [email protected]. For questions on the information provided they should contact 800-258-5361 (Smiths Medical's Customer Service Department). For questions regarding this recall call 1-800-332-0178.
Quantity in commerce: 190
Distribution: 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.
Product codes and lots: 1991524 1997100 2033224 2051222 2116286 2183921 2192487 2210967 2229821 2237453

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2268-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2268-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-23
Z-2269-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-23

Product code DYB

K871132Class IIPharmacia Deltec Subclavian IntroducersDeltec Systems, Inc. / cleared 1987-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)