FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
- Recall number
- Z-0932-2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
- Status
- Terminated
- Initiated
- 2022-03-08
- Posted
- not on file
- Terminated
- 2023-03-20
- Reason
- Product was improperly store which may cause a delay in results.
- 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
- 45 ea
- Distribution
- US distribution only - AL, CA, FL, GA, IL, IN, LA, MO, MS, NC, NE, NY, OH, PA, VA, and WA
- Lot, serial or model codes
- Model/Item No. S-O2440058; Lots 171793, 169614, 167181, 171713 UDI: 00657498000519
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JIN
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28