Z-0964-2024Class II

MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A

Name: Z-0964-2024 MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-12-21
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-12-21 / Open, Classified / root cause: labeling and UDI

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A on 2023-12-21. FDA classified it as Class II and gives the reason as "Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0964-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-21
Posted: 2024-02-01
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
Product code: OIB Blood And Urine Collection Kit (Excludes Hiv Testing)
Reason for recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: MEDLINE INDUSTRIES, LP issued an IMMEDIATE ACITON REQUIRED RECALL notice to its' consignees on 12/21/2023 via US mail and email. The notice explained the issue, potential risk, and requested the following actions: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-23-222-FG Recall Code: 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers document and destroy any affected product, and include your customer s quantities on your response form.
Quantity in commerce: 775 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 40195327239849 (case), 10195327239848 (unit), Lot Numbers: 23JBM366

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0964-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0963-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0964-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0965-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0966-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0967-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0968-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0969-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01

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)