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U.S. Department of Health and Human Services

Class 2 Device Recall Regard Clinical Packaging Solutions

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  Class 2 Device Recall Regard Clinical Packaging Solutions see related information
Date Initiated by Firm November 04, 2021
Date Posted December 22, 2021
Recall Status1 Terminated 3 on August 07, 2023
Recall Number Z-0411-2022
Recall Event ID 89078
Product Classification Labor and Delivery Kit - Product Code MLS
Product regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Code Information Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information Contact Ms. Lacy Stewart
417-647-3205
Manufacturer Reason
for Recall		 The kit contains a non-sterile needle.
FDA Determined
Cause 2		 Process control
Action The firm issued a letter dated 11/4/2021 via email on 11/4/2021 explaining the reason for recall, the health risk involved, and the actions to be taken by the customer. The customer was requested to check their inventory for the affected kits and immediately quarantine them without further distribution. The attached reply form was to be completed so that return of the affected kits could be arranged. If the kits were further distributed, the customer was requested to notify their customers.
Quantity in Commerce 40 kits
Distribution Distribution was made to Missouri. There was no foreign/military/government distribution.
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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