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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion Convenience Kits

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  Class 2 Device Recall Centurion Convenience Kits see related information
Date Initiated by Firm April 29, 2015
Create Date July 20, 2016
Recall Status1 Terminated 3 on November 03, 2016
Recall Number Z-2250-2016
Recall Event ID 74604
Product Classification Light, surgical, ceiling mounted - Product Code FSY
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
Code Information 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 
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information Contact Lisa A. Carpenter
517-546-5400 Ext. 1156
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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