Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0932-2022Class II

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

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-03-08 / Terminated

MEDLINE INDUSTRIES, LP - Northfield began a recall of Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL) on . FDA classified it as Class II and gives the reason as "Product was improperly store which may cause a delay in results". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0932-2022
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
Product code
JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Reason for recall
Product was improperly store which may cause a delay in results.
FDA root cause
Storage
Action
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.
Quantity in commerce
45 ea
Distribution
US distribution only - AL, CA, FL, GA, IL, IN, LA, MO, MS, NC, NE, NY, OH, PA, VA, and WA
Product codes and lots
Model/Item No. S-O2440058; Lots 171793, 169614, 167181, 171713  UDI: 00657498000519

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0932-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0932-2022Class IITerminatedVoluntary: Firm initiated