FDA Medical Device Recalls (openFDA)
Centurion Medical Products Corporation: Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY
- Recall number
- Z-2250-2016
- Recalling firm
- Centurion Medical Products Corporation
- Product
- Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY
- Status
- Terminated
- Initiated
- 2015-04-29
- Posted
- not on file
- Terminated
- 2016-11-03
- Reason
- Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufacturer, Medtronic. According to the notice received from Medtronic, the recall was initiated because some light covers may have splits or holes, which may result in the transfer of microorganisms from the light handle into the patient wound.
- Root cause
- Nonconforming Material/Component
- Action
- On 4/28/2015, URGENT PRODUCT RECALL NOTICE notifications were sent to the affected customers via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
- Quantity
- 483
- Distribution
- KS, IN, IA, KY, MT, SD
- Lot, serial or model codes
- Code Lot # Description exp date SUT18365 2012070350 ED SUTURE KIT Sep-14 MNS6710 2012070990 VAGINAL DELIVERY TRAY Jan-15 MNS6710 2012082090 VAGINAL DELIVERY TRAY Feb-15 MNS6710 2012092490 VAGINAL DELIVERY TRAY Apr-15 MNS6710 2012120390 VAGINAL DELIVERY TRAY Apr-15 MNS4635 2012081390 ENDOSCOPY TRAY Feb-15 OR1640 2012040990 MINOR BASIN SET Jan-15 OR1640 2012123190 MINOR BASIN SET Apr-15 OR1575 2012071690 LAPAROSCOPIC BASIN TRAY Nov-14 OR1575 2012091090 LAPAROSCOPIC BASIN TRAY Feb-15 OR1575 2013010490 LAPAROSCOPIC BASIN TRAY Apr-15
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSY
- 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