Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Regard

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall Regardsee related information
Date Initiated by FirmFebruary 24, 2022
Create DateMarch 30, 2022
Recall Status1 Terminated 3 on April 25, 2022
Recall NumberZ-0837-2022
Recall Event ID 89710
510(K)NumberK991088 
Product Classification I.V. start kit - Product Code LRS
ProductRegard 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 ContactLacy Stewart
417-730-3900
Manufacturer Reason
for Recall		Recalled devices were packaged in convenience kits.
FDA Determined
Cause 2		Material/Component Contamination
ActionA 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 Commerce1750 kits
DistributionUS Nationwide distribution in the state of Missouri.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LRS
-
-