FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
- Recall number
- Z-0404-2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
- Status
- Terminated
- Initiated
- 2021-11-30
- Posted
- not on file
- Terminated
- 2023-01-06
- Reason
- Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
- Root cause
- Storage
- Action
- The firm distributed an Urgent Recall Notification, dated 11/30/2021, to customers who purchased recalled product via first class mail. The notification informs customers that the firm is initiating a removal of Trilevel Serum Matrix Free from S-O2460605 kits due to product being compromised during shipment. Customers are instructed to immediately check their stock for affected product, quarantine any lot numbers associated with the recall, and destroy affected product. Customers were provided an Urgent Remedial Action Destruction Form to complete and return to the firm to indicate whether or not they possess recalled product and document product destruction. Completed forms are to be returned to the firm via email at recalls@medline.com or by fax at 866-767-1290. If product was further distributed, customers are required to share the recall notification down the distribution chain. Customers with any questions about the recall are instructed to call 866-359-1704.
- Quantity
- 14 units (individual)
- Distribution
- US Nationwide distribution in the states of IL, OH, MS, and PA.
- Lot, serial or model codes
- Model No.: S-O2460605; Batch No.: 161603, 165148, 156205, 158144, 169124, 171961, and 175250; Serial No.:161603, 165148, 156205, 158144, 169124, 171961, and 175250.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DIF
- 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