Z-2250-2016Class II

Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY...

Name: Z-2250-2016 Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY...
Creator: Centurion Medical Products Corporation
Published: 2015-04-29
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2015-04-29 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC... on 2015-04-29. FDA classified it as Class II and gives the reason as "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...". 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-2250-2016
Classification: Class II
Status: Terminated
Initiated: 2015-04-29
Posted: 2016-07-20
Terminated: 2016-11-03
Recalling firm: Centurion Medical Products, LP
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
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 483
Distribution: KS, IN, IA, KY, MT, SD
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2250-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2250-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-20

Product code FSY

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)