FDA Recall Terminated

Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY ID1670 I&D TRAY ID1715 INCISION & DRAINAGE TRAY ID1765 ER I&D PACK ID1765 ER I&D PACK ID1835 I & D TRAY ID2075 I&D TRAY ID585 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY

Recall: Z-1065-2020 · Initiated December 11, 2019

Recall

Recall Number: Z-1065-2020
Event Number: 84530
Firm: Centurion Medical Products Corporation
FEI Number: 3008403546
Product Code: LRP
Status: Terminated
Root Cause: Packaging process control
Initiated: December 11, 2019
Terminated: September 4, 2020
Address: 100 Centurion Way, Williamston, MI, 48895-9086

Description

Reason

Incomplete seals on the sterile package may compromise the sterility

Action

Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please 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, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.

Distribution

Nationwide Foreign: GHANA