Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Summary
The FDA issued a Class I for Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 118810 by Cardinal Health 200, LLC. Reason: Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility .
Details
Source
Device Recall
External ID
Z-0310-2025
Action Date
2024-11-20
Status
Ongoing
Category
device
Product Description
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Lot/Code Info: UDI/DI 10192253034783 (EA), Lot Number 221201, exp. 2027-11-30; UDI/DI 20192253034780 (BX), Lot Number 230201, exp. 2028-01-31; UDI/DI 50192253034781 (CS), Lot Number 230202,exp. 2028-02-01
Quantity Affected: 371,326 units
Reason for Recall
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-25
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 242 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-0310-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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