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U.S. Department of Health and Human Services

Class 2 Device Recall Core Biopsy Tray

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  Class 2 Device Recall Core Biopsy Tray see related information
Date Initiated by Firm August 10, 2021
Create Date November 18, 2021
Recall Status1 Terminated 3 on June 16, 2023
Recall Number Z-0251-2022
Recall Event ID 88463
Product Classification General surgery tray - Product Code LRO
Product REGARD Core Biopsy Tray
Code Information Lots numbers: 88004C, 87367C, 86986C, 83380C, 83062C, 82614C, 86178C and 85427C
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information Contact Lacy Stewart
417-730-3900
Manufacturer Reason
for Recall		 Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The correction was sent via e-mail on 08-10-2021 instructing the consignees to removed the Swabsticks (3's) and be discarded at time of use.
Quantity in Commerce 1,200 trays
Distribution US Nationwide in the states of FL, LA and MO.
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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