FDA Medical Device Recalls (openFDA)
Centurion Medical Products Corporation: Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
- Recall number
- Z-0344-2020
- Recalling firm
- Centurion Medical Products Corporation
- Product
- Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
- Status
- Terminated
- Initiated
- 2019-10-24
- Posted
- not on file
- Terminated
- 2020-06-24
- Reason
- Sterile packaging incomplete seals may compromise sterility of the product
- 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
- 80 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot/Batch Number: 2019052190 Exp Date: 5/31/2024
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 3008403546
- Firm city
- Williamston
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28