FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
- Recall number
- Z-0965-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
- Status
- Open, Classified
- Initiated
- 2023-12-21
- Posted
- 2024-02-01
- Terminated
- not on file
- Reason
- 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
- 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
- 4320 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/DI 40195327347551 (case), 10195327347550 (unit), Lot Numbers: 23KBC138
- 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