Devices

Device Recall 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2

Model / Serial
Item No. SC124. Lot No. 2774006, 2778500, 2783068, 2794495.
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
30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE¿ Stopcock, || Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 1 || Ext, Part No. A1000, Item No. SC124 || 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 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2

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

One device with a similar name

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Device Recall 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2

Model / Serial
Lot No. 2767376
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
8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 || Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 || 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.

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