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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE

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  Class 2 Device Recall MEDLINE see related information
Date Initiated by Firm December 21, 2023
Date Posted February 01, 2024
Recall Status1 Open3, Classified
Recall Number Z-0966-2024
Recall Event ID 93731
Product Classification Blood and urine collection kit (excludes HIV testing) - Product Code OIB
Product MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
Code Information UDI/DI 40195327323333 (case), 10195327323332 (unit), Lot Numbers: 23KBH642
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer 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.
FDA Determined
Cause 2		 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 500 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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