—#176323

Product

Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR

FDA product code: HFX — Clamp, Circumcision
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K890897
Affected lot / code info: Batch/Lot: 2019061801

Why it was recalled

A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.

Root cause (FDA determination)

Process control

Action the firm took

Centurion Medical Products issued Notification via Certified Mail, Return Receipt on 8/28/19 to customers who received affected product. Letter states reason for recall, helath risk and action to take: identify inventory within your possession and cease use immediately. Complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter as directed. Upon receipt of your response Centurion Representative will contact you regarding retrieval of the product from your facility, if required. Forward this recall information to any facilities to whom this product may have been further distributed, instructing them to cease use immediately. Questions: Kara A. Kowalczy Director of Quality Assurance(517) 546-5400 Ext.1122. Centurion mailed four (4) additional customer letters on 9/27 /2019 via Certified Mail, Return Receipt.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2019-08-28
Terminated: 2020-07-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176323. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.