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U.S. Department of Health and Human Services

Class 2 Device Recall Port Access Kit

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  Class 2 Device Recall Port Access Kit see related information
Date Initiated by Firm July 15, 2019
Create Date October 31, 2019
Recall Status1 Terminated 3 on August 31, 2020
Recall Number Z-0255-2020
Recall Event ID 83542
Product Classification General surgery tray - Product Code LRO
Product Kit, Port Access
Product Code: DYNDC1582A
Code Information Lot Number Expiration 2018121350 8/31/2020 2019020750 9/30/2020 2019031550 4/30/2021 2019041550 4/30/2021 2019061750 1/31/2021 2019062450 4/30/2021  
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information Contact Lisa A. Carpenter
517-545-1156
Manufacturer Reason
for Recall		 Supplier initiated recall of the GRIPPER Needles
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 1. Please identify all inventory that you have within your possession and cease use immediately. 2. 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. Upon receipt of this record, Centurion Representative will contact you regarding retrieval of the product from your facility. 3. Please forward this recall information to any facilities to who this product may have been further distributed, instructing them to cease use immediately.
Quantity in Commerce 11260 kits
Distribution IL
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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