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MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A recallZ-0963-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Dec 21, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Error in labeling

What the company is doing

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.

Recall details

Recall number
Z-0963-2024
Status
Open, Classified
Initiated by the company
Dec 21, 2023
Posted by the FDA
Feb 1, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
13860 units
Product code
OIB
Distribution
US Nationwide distribution.

Product description

MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A

Code information (models, lots, serial numbers)

UDI/DI 40195327139958 (case), 10195327139957 (unit), Lot Numbers: 23JBH262 and 23JBC264

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93731).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page