Z-0837-05

Centurion brand CirClamp with 1.1 cm bell, sterile, single use; product 310

Name: Z-0837-05 Centurion brand CirClamp with 1.1 cm bell, sterile, single use; product 310
Creator: Tri-State Hospital Supply Corp
Published: 2005-04-12
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2005-04-12 / Terminated / root cause: labeling and UDI

FDA source

Tri-State Hospital Supply Corp began a recall of Centurion brand CirClamp with 1.1 cm bell, sterile, single use; product 310 on 2005-04-12. The reason FDA records is "Not labeled as reprocessed, when this lot has been reprocessed". 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-0837-05
Status: Terminated
Initiated: 2005-04-12
Posted: 2005-05-12
Terminated: 2005-09-08
Recalling firm: Centurion Medical Products, LP
Product: Centurion brand CirClamp with 1.1 cm bell, sterile, single use; product 310.
Product code: HFX Clamp, Circumcision
Reason for recall: Not labeled as reprocessed, when this lot has been reprocessed.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified to return the product via letter dated 4/12/05.
Quantity in commerce: 1572
Distribution: Nationwide.
Product codes and lots: Lot 11224.

Product code HFX

K890897Class IICenturion CirclampTri-State Hospital Supply Corp. / cleared 1989-03-28

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)