Devices

Device Recall 7" Smallbore Ext Set w/MicroClave, Clave TConnector, Clamp, Rotating Luer

Model / Serial
Lot number 3482848, UDI (01) 0 0887709 01806 8 (17) 220701 (30) 01 (10) 3482848; lot number 3511823, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3511823; lot number 3516092, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3516092; and lot number 3545075, UDI (01) 0 0887709 01806 8 (17) 221001 (30) 01 (10) 3545075.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
Product Description
7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. || The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Manufacturer
ICU Medical, Inc.
1 Event
- Recall of Device Recall 7" Smallbore Ext Set w/MicroClave, Clave TConnector, Clamp, Rotating Luer

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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