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U.S. Department of Health and Human Services

Class 2 Device Recall CenturionSkin Prep Trays

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  Class 2 Device Recall CenturionSkin Prep Trays see related information
Date Initiated by Firm December 11, 2019
Create Date February 05, 2020
Recall Status1 Terminated 3 on September 04, 2020
Recall Number Z-1092-2020
Recall Event ID 84530
Product Classification Skin prep tray - Product Code OJU
Product Centurion-Skin Prep Trays
Code Information Product/Description/Lot Numbers: SP1180 DRY PREP SET 2019032690 SP200 SKIN SCRUB TRAY 2019051390 SP415 STERILE GAUZE SPONGE 2019011090, 2018120390  
Recalling Firm/
Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Incomplete seals on the sterile package may compromise the sterility
FDA Determined
Cause 2
Packaging process control
Action Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.
Distribution Nationwide Foreign: GHANA
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.