Recalls / —

—#177443

Product

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

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

Lot/Batch Number: 2019052190 Exp Date: 5/31/2024

Why it was recalled

Sterile packaging incomplete seals may compromise sterility of the product

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm

Centurion Medical Products Corporation

Address

100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2019-10-24

Terminated

2020-06-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #177443. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.