Recall Z-0310-2025— Cardinal Health 200, LLC
Class I · Ongoing
Class I FDA medical device recall by Cardinal Health 200, LLC, initiated 2024-09-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777. 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 with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-09-25
- Firm location
- Waukegan, IL, United States
Product description
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.