Recall Z-0848-2024— Cardinal Health 200, LLC
Class I · Ongoing
Class I FDA medical device recall by Cardinal Health 200, LLC, initiated 2023-12-28. It names one FDA 510(k) clearance: K190502. Product: Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE. Reason: The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-12-28
- Firm location
- Waukegan, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
Reason for recall
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
Data sourced from openFDA. This site is unofficial and independent of the FDA.