Devices

Device Recall 184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave, 2 AntiSyphon

Model / Serial
Item No. 011-A1095. Lot No. 2776972, 2785650, 2796669.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.
Product Description
184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon || Valves, 0.2 Micron Positive Filter, BCV-Clave¿, NanoClave¿ TConnector, || Rotating Luer, Part No. A1000, Item No. 011-A1095 || The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
Manufacturer
ICU Medical, Inc.
1 Event
- Recall of Device Recall 184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave, 2 AntiSyphon

Manufacturer

ICU Medical, Inc.

Manufacturer Address
ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
Manufacturer Parent Company (2017)
ICU Medical, Inc.
Source
USFDA

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