Z-0724-2007

Smith & Nephew Suture Passer 12 inch Part Number: 7209166

Name: Z-0724-2007 Smith & Nephew Suture Passer 12 inch Part Number: 7209166
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2007-03-01
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2007-03-01 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew Suture Passer 12 inch Part Number: 7209166 on 2007-03-01. The reason FDA records is "Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0724-2007
Status: Terminated
Initiated: 2007-03-01
Posted: 2007-04-07
Terminated: 2008-07-14
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew Suture Passer 12 inch Part Number: 7209166
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Smith & Nephew notified accounts by letter on 3/1/07, users are advised to destroy product and return unused product in their inventory. A reply form is required to be completed.
Quantity in commerce: 12, 292 units for all recalls Z-0724-0726-07
Distribution: World wide- USA and Canada, Belgium. Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Italy, Netherlands, Portugal, Austria, Ireland, Sweden, Argentina. Chile, Columbia, Brazil, China. Japan, Korea, Thailand, Hong Kong, Malaysia. Taiwan, Singapore, India, , Dubai, Mexico, Australia, Egypt. Switzerland, New Zealand and Norway
Product codes and lots: All lot codes

Product code NBW

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)