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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 November 01, 2023
Date Posted November 16, 2023
Recall Status1 Open3, Classified
Recall Number Z-0313-2024
Recall Event ID 93379
Product Classification Tray, blood collection - Product Code GJE
Product 24 BLOOD CULTURE KIT, REF DYNDH1632
Code Information UDI/DI 40193489916141 (case), 10193489916140 (unit): Lot Numbers: 23EMF710, 23DMF154, 23DMA779
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		 This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
FDA Determined
Cause 2		 Under Investigation by firm
Action Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 11/01/2023 via email. The notice explained the issue and requested that the destruction of the affected kits. Consignees were also instructed to notify all parties if the kits were transferred.
Quantity in Commerce 3160 kits
Distribution US Nationwide distribution in the state of California.
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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