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Terminated

Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR

FDA Recall Z-0121-2020 · Posted None

Recall StatusTerminated
Product CodeHFX
Date Initiated2019-08-28
Date Terminated2020-07-23
Product Quantity204 each

Reason for Recall

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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