Date Initiated by Firm | October 23, 2017 |
Create Date | March 17, 2018 |
Recall Status1 |
Terminated 3 on June 21, 2018 |
Recall Number | Z-1080-2018 |
Recall Event ID |
79329 |
Product Classification |
Tray, surgical - Product Code LRP
|
Product | GENERAL PURPOSE INSTRUMENT TRAY |
Code Information |
75121 75175 71435 75455 75690 SR245 Lot codes: 2017071990 2016110990 2016040790 2017022090 2016112490 2017010390 2017082390 2015101290 2015111790 2016032290 2016051790 2016053090 2016102490 2017013190 2017032990 2017080290 2015110390 2016010490 2016012090 2016020890 2016041890 2016061390 2016090590 2016110790 2017010990 2017021390 2017032190 2015092190 2015120190 2015121490 2016022590 2016120190 2017010390 2017011090 2015093090 2015112390 2016020390 2016092290 2016091590 |
Recalling Firm/ Manufacturer |
Centurion Medical Products Corporation 100 Centurion Way Williamston MI 48895-9086
|
Manufacturer Reason for Recall | Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | On October 16, 2017 a PRODUCT CORRECTION letter was issued to customers notifying them that if they had any kits in their inventory, Centurion will supply labels to affix to the front of each kit instructing the user to discard the prep pad upon opening the kit. Other components of the kit may continue to be used and are NOT within the scope of this recall. |
Distribution | Nationally |
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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