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U.S. Department of Health and Human Services

Class 3 Device Recall Regard

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  Class 3 Device Recall Regard see related information
Date Initiated by Firm February 24, 2022
Create Date March 30, 2022
Recall Status1 Terminated 3 on April 25, 2022
Recall Number Z-0837-2022
Recall Event ID 89710
510(K)Number K991088  
Product Classification I.V. start kit - Product Code LRS
Product Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Code Information IV START LABOR BIRTH convenience kits: 1) Item No. 830110, Lots 89222 and 87572 (exp. MAR/12/2022 2) Item No. 830110002, Lots 91226, 90641, and 90446 (exp. MAY/12/2022)
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
Recalled devices were packaged in convenience kits.
FDA Determined
Cause 2
Material/Component Contamination
Action A customer letter dated February 24, 2022 was issued to the impacted consignee. The letter instructs the consignee to perform a microscopy to confirm an elevated RBC count in a urine sample as the impacted component may shed contaminant particles that are identified as RBCs when used in conjunction with the Sysmex UF-1000i or UX-2000 analyzers. A reply form should be completed and returned to ROi confirming receipt and understanding of the notification. End users should retain a copy of the BD notice and post near the analyzer as a visual reminder of the potential issue with the BD product.
Quantity in Commerce 1750 kits
Distribution US Nationwide distribution in the state of Missouri.
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 = LRS and Original Applicant = BECTON DICKINSON VACUTAINER SYSTEMS
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