Devices

Device Recall PROXIMALE 28 cm (11") Smallbore Ext Set

Model / Serial
Lot No. 3316827. Item No. 011-AM6118
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
Product Description
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer. || Product Usage: || The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)..
Manufacturer
ICU Medical, Inc.
1 Event
- Recall of Device Recall PROXIMALE 28 cm (11") Smallbore Ext Set

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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