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U.S. Department of Health and Human Services

Class 2 Device Recall OPHTHALMIC DRESSING TRAY

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  Class 2 Device Recall OPHTHALMIC DRESSING TRAY see related information
Date Initiated by Firm March 09, 2017
Date Posted March 27, 2017
Recall Status1 Terminated 3 on August 07, 2017
Recall Number Z-1731-2017
Recall Event ID 76730
Product Classification Dressing change tray - Product Code OXQ
Product OPHTHALMIC DRESSING TRAY

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: 2016081750 4/30/19 2016080450 12/31/18 2016060250 10/31/18 2015091050 4/30/18 2015090350 4/30/18 2015083150 4/30/18 2015012750 10/31/17 2015012250 10/31/17 2014061850 4/30/17
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		 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
Action On 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 Commerce 210 kits
Distribution US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL
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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