FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: BLOOD CULTURE KIT, REF DYNDH1647B
- Recall number
- Z-0314-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- BLOOD CULTURE KIT, REF DYNDH1647B
- Status
- Open, Classified
- Initiated
- 2023-11-01
- Posted
- 2023-11-16
- Terminated
- not on file
- Reason
- This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
- Root cause
- Under Investigation by firm
- Action
- Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 11/01/2023 via email. The notice explained the issue and requested that the destruction of the affected kits. Consignees were also instructed to notify all parties if the kits were transferred.
- Quantity
- 1890 kits
- Distribution
- US Nationwide distribution in the state of California.
- Lot, serial or model codes
- UDI/DI 40195327267002 (case), 10195327267001 (unit): Lot Numbers: 23CMH028, 23CMD954
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OIB
- 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