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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 23, 2017
Create Date March 17, 2018
Recall Status1 Terminated 3 on June 21, 2018
Recall Number Z-1087-2018
Recall Event ID 79329
Product Classification Tray, surgical - Product Code LRP
Code Information DT875  Lot codes: 2015102090 2015120290 2016012190 2016032290 2016052690 2016072890 2016090590 2017010490 2017020790 2017032190 2017042790 
Recalling Firm/
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

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.