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U.S. Department of Health and Human Services

Class 2 Device Recall CenturionIncision /Drainage Tray

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 Class 2 Device Recall CenturionIncision /Drainage Traysee related information
Date Initiated by FirmDecember 11, 2019
Create DateFebruary 05, 2020
Recall Status1 Terminated 3 on September 04, 2020
Recall NumberZ-1065-2020
Recall Event ID 84530
Product Classification Tray, surgical - Product Code LRP
ProductCenturion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY ID1670 I&D TRAY ID1715 INCISION & DRAINAGE TRAY ID1765 ER I&D PACK ID1765 ER I&D PACK ID1835 I & D TRAY ID2075 I&D TRAY ID585 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY
Code Information Lot Numbers:  ID1235A ESKENAZI INCISION & DRAINAGE TRAY 2019020890 ID1525 INCISION & DRAINAGE TRAY 2019052890 ID1670 I&D TRAY 2019050890 ID1715 INCISION & DRAINAGE TRAY 2018121390 ID1765 ER I&D PACK 2019042290 ID1765 ER I&D PACK 2019021190 ID1835 I & D TRAY 2019041290 ID2075 I&D TRAY 2019052990 ID585 INCISION & DRAINAGE TRAY 2019022090 ID875 INCISION & DRAINAGE TRAY 2019020590 ID875 INCISION & DRAINAGE TRAY 2019011790 
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information ContactSAME
517-546-5400
Manufacturer Reason
for Recall		Incomplete seals on the sterile package may compromise the sterility
FDA Determined
Cause 2		Packaging process control
ActionCenturion 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.
DistributionNationwide Foreign: GHANA
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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