Z-0311-2024 Class II Ongoing
FDA device recall Z-0311-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on November 1, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1770 kits.
Recall Details
- Product Type
- Devices
- Report Date
- November 22, 2023
- Initiation Date
- November 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1770 kits
Product Description
PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
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.
Distribution Pattern
US Nationwide distribution in the state of California.
Code Information
UDI/DI 40193489402811 (case), 10193489402810 (unit): Lot Numbers: 23EMF711, 23CMH027