Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
Summary
The FDA issued a Class I for Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777 by Cardinal Health 200, LLC. Reason: Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syr.
Details
Source
Device Recall
External ID
Z-0852-2024
Action Date
2024-02-14
Status
Ongoing
Category
device
Product Description
Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
Lot/Code Info: UDI/DI 50192253033517 (Case), 20192253033516 (Box), 10192253033519 (Each), Lot Numbers: 230201, 230202, 221201, 221202, 230203, 230204, 230205, 230206, 230208, 230209, 230210, 230211, 230212, 230213, 230214, 230215, 230216, 230217, 230218, 230219, 230207, 230602, 230601, 230602, 230603, 230701, 230702, 230703, 230704, 230705, 230706, 230707
Reason for Recall
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Distribution
Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-28
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 274 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-0852-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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