Z-1276-03

ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025...

Name: Z-1276-03 ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025...
Creator: International Surgical Supply, Inc.
Published: 2003-09-03
License: https://open.fda.gov/license/

International Surgical Supply, Inc. / initiated 2003-09-03 / Terminated / root cause: sterility

FDA source

International Surgical Supply, Inc. began a recall of ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or... on 2003-09-03. The reason FDA records is "Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1276-03
Status: Terminated
Initiated: 2003-09-03
Posted: 2003-09-23
Terminated: 2012-05-06
Recalling firm: International Surgical Supply, Inc.
Product: ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Thoracic Trocar Sleeve, rounded tip, Item # TT012.
Product code: KDC Instrument, Surgical, Disposable
Reason for recall: Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
Root cause tag: sterility
FDA root cause: Other
Action: The firm sent an e-mail recall notification and request for response on 9/3/2003, to the one direct account in Minnesota requesting quarantine and return of product and also subrecall down to the hospital/health professional level.
Quantity in commerce: 54
Distribution: Product was distributed to a direct consignee/distributor in Minnesota and also directly to the only two hospital/health professional accounts involved both in Tennessee.
Product codes and lots: All codes

Product code KDC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)