Z-0149-2024 Class I Ongoing
FDA device recall Z-0149-2024 was initiated by Cardinal Health 200, LLC on September 20, 2023 and is designated Class I. Reason for recall: Demonstrated recognition and compatibility issues with syringe infusion pumps. The recall status is ongoing. Affected quantity: 1,097,048 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- September 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,097,048 units
Product Description
Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
Reason for Recall
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Distribution Pattern
US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.
Code Information
Product Code: 1183500777; UDI/DI: 10192253034691 - each, 20192253034698 - box, 50192253034699 - case; Lot Numbers: 221201, 230201, 230601, 230602