| Class 2 Device Recall Centurion Convenience Kits | |
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 |
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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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