FDA Medical devices recall ·
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0310-2025
- Date
- (initiated September 25, 2024)
- Company / brand
- Cardinal Health 200, LLC
3651 Birchwood Dr, Waukegan, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 371,326 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Nationwide
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0310-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.