28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, 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).
Reported: July 19, 2017 Initiated: May 30, 2017 #Z-2719-2017
Product Description
28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, 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).
Reason for Recall
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- 6 units
- Distribution
- Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, 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).. Recalled by ICU Medical, Inc.. Units affected: 6 units.
Why was this product recalled? ▼
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 19, 2017. Severity: Moderate. Recall number: Z-2719-2017.
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