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U.S. Department of Health and Human Services

Class 2 Device Recall Gripper Needle (Centurion Convenience Kits)

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  Class 2 Device Recall Gripper Needle (Centurion Convenience Kits) 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-0253-2020
Recall Event ID 83542
510(K)Number K021999  
Product Classification Tray, surgical - Product Code LRP
Product Port full Access Tray
Product Code: DT19330
Code Information Lot Number Expiration 2018092801 12/31/2019 2018121401 5/31/2020 2019022601 6/30/2020 2019032901 6/30/2020 
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 240 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.
510(K) Database 510(K)s with Product Code = LRP and Original Applicant = DELTEC, INC.
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