FDA Medical Device Recalls (openFDA)
Centurion Medical Products Corporation: Centurion- LC145 STERILE NICU LINE CHANGE KIT
- Recall number
- Z-1086-2020
- Recalling firm
- Centurion Medical Products Corporation
- Product
- Centurion- LC145 STERILE NICU LINE CHANGE KIT
- Status
- Terminated
- Initiated
- 2019-12-11
- Posted
- not on file
- Terminated
- 2020-09-04
- Reason
- Incomplete seals on the sterile package may compromise the sterility
- Root cause
- Packaging process control
- Action
- Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) 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, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.
- Quantity
- 160
- Distribution
- Nationwide Foreign: GHANA
- Lot, serial or model codes
- Lot Code: 2018111590
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OXQ
- 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