Z-0314-2024Class II

Blood Culture Kit, Ref Dyndh1647b

Name: Z-0314-2024 Blood Culture Kit, Ref Dyndh1647b
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-11-01
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-11-01 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of BLOOD CULTURE KIT, REF DYNDH1647B on 2023-11-01. FDA classified it as Class II and gives the reason as "This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0314-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-01
Posted: 2023-11-16
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Blood Culture Kit, Ref Dyndh1647b
Product code: OIB Blood And Urine Collection Kit (Excludes Hiv Testing)
Reason for recall: This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
FDA 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 in commerce: 1890 kits
Distribution: US Nationwide distribution in the state of California.
Product codes and lots: UDI/DI 40195327267002 (case), 10195327267001 (unit): Lot Numbers: 23CMH028, 23CMD954

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0314-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0310-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-16
Z-0311-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-16
Z-0312-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-16
Z-0313-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-16
Z-0314-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-16

Product code OIB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)