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Terminated

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

FDA Recall Z-0344-2020 · Posted None

Recall StatusTerminated
Product CodeLRO
Date Initiated2019-10-24
Date Terminated2020-06-24
Product Quantity80 units

Reason for Recall

Sterile packaging incomplete seals may compromise sterility of the product

Firm 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

Root Cause

Process control

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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