Summary
The FDA issued a Class I for Monoject 20 mL Syringe Luer-Lock Tip Soft Pack by Cardinal Health 200, LLC. Reason: Demonstrated recognition and compatibility issues with syringe infusion pumps..
Details
Source
Device Recall
External ID
Z-0148-2024
Action Date
2023-11-01
Status
Ongoing
Category
device
Product Description
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Lot/Code Info: Product Code: 1182000777; UDI/DI: 10192253034677 - each, 20192253034674 - box, 50192253034675 - case; Lot Numbers: 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, 230206
Quantity Affected: 4,913,520 units
Reason for Recall
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-20
Company
Waukegan, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 183 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health 200, LLC have FDA actions?
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0148-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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