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U.S. Department of Health and Human Services

Class 2 Device Recall EYE KIT

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 Class 2 Device Recall EYE KITsee related information
Date Initiated by FirmMarch 09, 2017
Date PostedMarch 27, 2017
Recall Status1 Terminated 3 on August 07, 2017
Recall NumberZ-1733-2017
Recall Event ID 76730
Product Classification Dressing change tray - Product Code OXQ
ProductEYE KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
Code Information Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2013120690 7/31/18 2013071890 10/31/17
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information ContactLisa A. Carpenter
517-546-5400 Ext. 1156
Manufacturer Reason
for Recall		Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier's recall because of potential breach in sterile packaging.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn March 9, 2017 Centurion Medical Products recalled specific lots of medical convenience kits due to a supplier initiated recall of Covidien Curity Eye Pads. All affected customers were notified, advised to discontinue use of associated kits, and requested to confirm the status of remaining stock to Centurion.
Quantity in Commerce120 kits
DistributionUS Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL
Total Product Life CycleTPLC 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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