Recall Z-1724-2022— ICU Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by ICU Medical, Inc., initiated 2022-08-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;. Reason: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing..
- Recalling firm
- ICU Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-01
- Firm location
- San Clemente, CA, United States
Product description
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
Reason for recall
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.