FDA Recall Terminated

Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955

Recall: Z-0344-2020 · Initiated October 24, 2019

Recall

Recall Number
Z-0344-2020
Event Number
84165
Firm
Centurion Medical Products Corporation
FEI Number
3008403546
Product Code
LRO
Status
Terminated
Root Cause
Process control
Initiated
October 24, 2019
Terminated
June 24, 2020
Address
100 Centurion Way, Williamston, MI, 48895-9086

Description

Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955

Reason

Sterile packaging incomplete seals may compromise sterility of the product

Action

Centurion medical issued notification was emailed to the affected distributor on October 24, 2019, Centurion's parent company, Med line Industries. Centurion mailed a letter to the single affected medical facility on 10/24/19, via certified mail, return receipt. The letter provides reason for recall, heath risk and action to take: be accessed for use. (1) Identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use 2) 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 as directed. Upon receipt of this record, your response will be documented, and a Centurion Representative will contact you regarding retrieval of the product from your facility, if required. 3) Please forward a copy of this notice to any facilities to whom this product may have been further distributed. Questions Contact Director of Quality Assurance, Centurion Medical Products Corporation (517) 546-5400 Ext.1122

Distribution

Nationwide

Quantity

80 units