CLASS II Device recall · Reported 27 Jul 2016 · FDA Enforcement Report
Convenience Kits from Centurion that contain recalled
Centurion Medical Products is recalling Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED Suture, distributed in Iowa, Indiana, Kansas, Kentucky, Montana, South Dakota. The recall was initiated on 29 Apr 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2250-2016
- FDA event ID
- 74604
- Recalling firm
- Centurion Medical Products, Williamston, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Apr 2015
- FDA classified
- 20 Jul 2016
- Reported
- 27 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 29 Apr 2015 | Recall initiated by company | |
| 20 Jul 2016 | Classified by FDA | +448 days |
| 27 Jul 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
KS, IN, IA, KY, MT, SD
Questions about this recall
Is Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED Suture recalled?
Yes. Centurion Medical Products recalled Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED Suture on 29 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-2250-2016.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
KS, IN, IA, KY, MT, SD
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
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| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |