MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
This recall is currently active, issued February 1, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- December 21, 2023
- Posted
- February 1, 2024
- Recall Number
- Z-0968-2024
- Quantity
- 4200 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI/DI 40195327509874 (case), 10195327509873 (unit), Lot Numbers: 23JBQ525
Root Cause
Error in labeling
Action Taken
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.