Class 2 Device Recall MEDLINE

• Date Initiated by Firm: November 01, 2023
• Date Posted: November 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0311-2024
• Recall Event ID: 93379
• Product Classification: Wound dressing kit - Product Code MCY
• Product: PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
• Code Information: UDI/DI 40193489402811 (case), 10193489402810 (unit): Lot Numbers: 23EMF711, 23CMH027
• 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: 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: 1770 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.