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U.S. Department of Health and Human Services

Class 2 Device Recall CenturionGeneral Surgery Convenience Kits

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  Class 2 Device Recall CenturionGeneral Surgery Convenience Kits 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-1052-2020
Recall Event ID 84530
Product Classification Tray, surgical - Product Code LRP
Product Centurion-General Surgery Convenience Kits
DYNDH1033B SUBCLAVIAN ON/OFF KIT
DYNDH1090A SDS PROCEDURE PACK
DYNDH1110 BIOPSY PACK
DYNDH1110 BIOPSY PACK
DYNDH1110 BIOPSY PACK
DYNDH1114 BIOPSY TRAY
DYNDH1131 WDC ULTRASOUND KIT
DYNDH1227A HOLSTON MYELOGRAM PACK
DYNDH1227A HOLSTON MYELOGRAM PACK
DYNDH1265 MYELOGRAM TRAY
DYNDH1272 LUMBAR PUNCTURE TRAY
DYNDH1281A PARA/THORA ULTRASOUND
DYNDH1285A BIOPSY ULTRASOUND
DYNDH1321 LUMBAR PUNCTURE TRAY
DYNDH1349 ARTHROGRAM TRAY
DYNDH1359 DIAGNOSTIC TRAY
DYNDH1397 GENERAL ASPIRATION TRAY - CHOICE
DYNDH1399 ARTHROGRAM TRAY
Code Information Lot Numbers:  DYNDH1033B SUBCLAVIAN ON/OFF KIT 2019061080 DYNDH1090A SDS PROCEDURE PACK 2019021990 DYNDH1110 BIOPSY PACK 2019032990 DYNDH1110 BIOPSY PACK 2019011590 DYNDH1110 BIOPSY PACK 2018092590 DYNDH1114 BIOPSY TRAY 2018111290 DYNDH1131 WDC ULTRASOUND KIT 2019030690 DYNDH1227A HOLSTON MYELOGRAM PACK 2019061090 DYNDH1227A HOLSTON MYELOGRAM PACK 2019022790 DYNDH1265 MYELOGRAM TRAY 2018101990 DYNDH1272 LUMBAR PUNCTURE TRAY 2019020590 DYNDH1281A PARA/THORA ULTRASOUND 2019040180 DYNDH1285A BIOPSY ULTRASOUND 2019051380 DYNDH1321 LUMBAR PUNCTURE TRAY 2019011590 DYNDH1349 ARTHROGRAM TRAY 2018121390 DYNDH1359 DIAGNOSTIC TRAY 2019040290 DYNDH1397 GENERAL ASPIRATION TRAY - CHOICE 2019031880 DYNDH1399 ARTHROGRAM TRAY 2019042290 
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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