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Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of… recallZ-0932-2022 · MEDLINE INDUSTRIES, LP - Northfield · initiated Mar 8, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Product was improperly store which may cause a delay in results.

FDA root cause category: Storage

What the company is doing

Consignees 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.

Recall details

Recall number
Z-0932-2022
Status
Terminated
Initiated by the company
Mar 8, 2022
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
45 ea
Product code
JIN
Distribution
US distribution only - AL, CA, FL, GA, IL, IN, LA, MO, MS, NC, NE, NY, OH, PA, VA, and WA

Product description

Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)

Code information (models, lots, serial numbers)

Model/Item No. S-O2440058; Lots 171793, 169614, 167181, 171713  UDI: 00657498000519

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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