Z-0344-2020Class II

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

Name: Z-0344-2020 Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
Creator: Centurion Medical Products Corporation
Published: 2019-10-24
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2019-10-24 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955 on 2019-10-24. FDA classified it as Class II and gives the reason as "Sterile packaging incomplete seals may compromise sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0344-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-24
Posted: 2019-11-06
Terminated: 2020-06-24
Recalling firm: Centurion Medical Products, LP
Product: Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
Product code: LRO General Surgery Tray
Reason for recall: Sterile packaging incomplete seals may compromise sterility of the product
Root cause tag: manufacturing process
FDA root cause: Process control
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
Quantity in commerce: 80 units
Distribution: Nationwide
Product codes and lots: Lot/Batch Number: 2019052190 Exp Date: 5/31/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0344-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0344-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-06

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)