Recall Z-0267-2021— ICU Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by ICU Medical, Inc., initiated 2020-07-06, terminated 2023-05-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per pouch, 25 pouches per case. UDI:(01)10840619060616(17)250201(30)25(10)4711366. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein. Reason: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike..
- Recalling firm
- ICU Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-06
- Terminated
- 2023-05-11
- Firm location
- San Clemente, CA, United States
Product description
135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per pouch, 25 pouches per case. UDI:(01)10840619060616(17)250201(30)25(10)4711366. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
Reason for recall
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Data sourced from openFDA. This site is unofficial and independent of the FDA.