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U.S. Department of Health and Human Services

Class 2 Device Recall Custom procedure packs

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  Class 2 Device Recall Custom procedure packs see related information
Date Initiated by Firm January 03, 2020
Create Date January 30, 2020
Recall Status1 Terminated 3 on November 20, 2020
Recall Number Z-0918-2020
Recall Event ID 84643
Product Classification General surgery tray - Product Code LRO
Product Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows:
a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012
b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027
c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026
d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024
e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011
f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028
g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084
h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014
i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034

Product Usage:
These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.
Code Information a) Item Number 830015012 Lot Numbers: 72700L, 74508L  b) Item Number: 830027 Lot Numbers: 72702C, 74406C  c) Item Number: 830026 Lot Numbers: 72897B  d) Item Number: 830024 Lot Numbers: 73325B, 74403B  e) Item Number, 880189011 Lot Numbers: 73173K, 74855K  f) Item Number: 830028 Lot Numbers: 73666B  g) Item Number 830084 Lot Numbers: 74354B  h) Item Number 830014 Lot Numbers: 74373N  i) Item Number 830034 Lot Numbers: 68336D 
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information Contact Cheyenne L. Stewart
417-730-3937
Manufacturer Reason
for Recall		 ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.
FDA Determined
Cause 2		 Other
Action The firm notified its direct consignee by letter disseminated by email on 01/03/2020. The direct consignee in turn notified the end user by email. The notice requested that the user follow the IFU and ensure a full and secure friction fit between the Continu-Flo Luer and the ONE-LINK connector.
Quantity in Commerce 412 packs
Distribution US: AR, OK, MO, KS
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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