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U.S. Department of Health and Human Services

Class 2 Device Recall Hydroxybutyrate LiquiColor Tests

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 Class 2 Device Recall Hydroxybutyrate LiquiColor Testssee related information
Date Initiated by FirmMarch 08, 2022
Create DateApril 14, 2022
Recall Status1 Terminated 3 on March 20, 2023
Recall NumberZ-0932-2022
Recall Event ID 89857
Product Classification Nitroprusside, ketones (urinary, non-quant.) - Product Code JIN
ProductHydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
Code Information Model/Item No. S-O2440058; Lots 171793, 169614, 167181, 171713  UDI: 00657498000519
FEI Number 1417592
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer Reason
for Recall		Product was improperly store which may cause a delay in results.
FDA Determined
Cause 2		Storage
ActionConsignees were notified via first class mail on March 08, 2022. Consignees are responsible for initiating sub-recalls, where necessary. Medline Industries, LP. has provided each consignee with a letter and a Destruction form to record their response to the recall notification. Each Response received will be recorded and Medline Industries, LP. will send subsequent letters to consignees that have not provided a response to the recall notification in the allotted time. Each consignee was provided with a destruction form to complete and return. The consignees are responsible to destroy their product per their local and state regulations. No product will be returned to Medline.
Quantity in Commerce45 ea
DistributionUS distribution only - AL, CA, FL, GA, IL, IN, LA, MO, MS, NC, NE, NY, OH, PA, VA, and WA
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.
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