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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion

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  Class 2 Device Recall Centurion 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-1095-2020
Recall Event ID 84530
Product Classification Breast biopsy / localization tray - Product Code PXP
Product Centurion-
P151659 BIOPSY TRAY
P243133 LATEX TUBING PACK
P243133 LATEX TUBING PACK
P243133 LATEX TUBING PACK
P261569 PACK BIOPSY
P392929 BMT-LACERATION PACK
P429589A TRAY BONE MARRO ASC LTX SAFE
P734457 SUTURE REMOVAL PACK LATEX SAFE
P751651A BIOPSY PROCEDURE PACK
P758486 PVP PREP PACK
P758486 PVP PREP PACK
P922260 ALCOHOL PREP PACK
P928310 WET PREP TRAY
P928310 WET PREP TRAY
P948416 LACERATION PACK
P966455A BREAST BIOPSY PACK-LF
Code Information Product/Lot Number: P151659 BIOPSY TRAY 2019031490 P243133 LATEX TUBING PACK 2019042590 P243133 LATEX TUBING PACK 2019031990 P243133 LATEX TUBING PACK 2019022190 P261569 PACK BIOPSY 2019021490 P392929 BMT-LACERATION PACK 2018121790 P429589A TRAY BONE MARRO ASC LTX SAFE 2019012590 P734457 SUTURE REMOVAL PACK LATEX SAFE 2019031990 P751651A BIOPSY PROCEDURE PACK 2019020890 P758486 PVP PREP PACK 2019041590 P758486 PVP PREP PACK 2019031990 P922260 ALCOHOL PREP PACK 2019041580 P928310 WET PREP TRAY 2019050690 P928310 WET PREP TRAY 2019031590 P948416 LACERATION PACK 2018110990 P966455A BREAST BIOPSY PACK-LF 2018122790 
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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