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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion Umbilical Trays

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  Class 2 Device Recall Centurion Umbilical 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-1058-2020
Recall Event ID 84530
Product Classification Tray, surgical - Product Code LRP
Product Centurion- Umbilical Trays
UVT1045 UMBILICAL ARTERY TRAY
UVT1055 UVC KIT
UVT1065 UMBILICAL VESSEL CATHETER TRAY
UVT170 UMBILICAL VESSEL TRAY W/O CATHETER
UVT280 UMBILICAL ARTERY TRAY
UVT460 UMBILICAL CATHETER TRAY
UVT505 UMBILICAL VESSEL CATH INSERT TR W/O CATH
UVT630 UMBILICAL/PICC/CHEST TUBE INS KIT
UVT640 UMBILICAL CATHETER INSERTION TRAY (P/S)
UVT665 UMBILICAL VESSEL CATHETER TRAY
UVT730 UMBILICAL VESSEL INSERTION TRAY
UVT795 UMBILICAL CATH TRAY
UVT960A UMBILICAL PICC/INSERTION TRAY
UVT960A UMBILICAL PICC/INSERTION TRAY
UVT970 CVC/UMBILICAL CATHETER INSERTION TRAY
Code Information Lot Numbers:  UVT1045 UMBILICAL ARTERY TRAY 2018100490 UVT1055 UVC KIT 2019021590 UVT1065 UMBILICAL VESSEL CATHETER TRAY 2019060790 UVT170 UMBILICAL VESSEL TRAY W/O CATHETER 2019040180 UVT280 UMBILICAL ARTERY TRAY 2018101890 UVT460 UMBILICAL CATHETER TRAY 2019050690 UVT505 UMBILICAL VESSEL CATH INSERT TR W/O CATH 2019020190 UVT630 UMBILICAL/PICC/CHEST TUBE INS KIT 2019012880 UVT640 UMBILICAL CATHETER INSERTION TRAY (P/S) 2019042290 UVT665 UMBILICAL VESSEL CATHETER TRAY 2018120590 UVT730 UMBILICAL VESSEL INSERTION TRAY 2019013190 UVT795 UMBILICAL CATH TRAY 2018120690 UVT960A UMBILICAL PICC/INSERTION TRAY 2019041790 UVT960A UMBILICAL PICC/INSERTION TRAY 2018121390 UVT970 CVC/UMBILICAL CATHETER INSERTION TRAY 2019032790 
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information Contact SAME
517-546-5400
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.
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