Recall Z-0121-2020

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.

FDA-determined cause: Process control

Action taken

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.