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U.S. Department of Health and Human Services

Class 2 Device Recall Regard

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  Class 2 Device Recall Regard see related information
Date Initiated by Firm April 20, 2020
Create Date June 05, 2020
Recall Status1 Terminated 3 on August 21, 2020
Recall Number Z-2265-2020
Recall Event ID 85591
Product Classification Plastic surgery and accessories kit - Product Code FTN
Product Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Code Information Lot no. 68336DRW. Item number: 830034. UDI: (01) 10326053106634 (17) 210131 (10) 68336DRW.
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information Contact
417-730-3900
Manufacturer Reason
for Recall		 Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
FDA Determined
Cause 2		 Other
Action ROi CPS, LLC notified customer on 04/23/2020 via "Urgent Medical Device Recall Notice" The recall letter identified the affected product requested the users to review their inventory and quarantine the affected lots. The consignees were asked to complete and return the recall form.
Quantity in Commerce 40 Kits.
Distribution US nationwide distribution in the states of MO, AR and OK.
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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