18 cm (7") 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).
FDA Recall Z-2716-2017 · Posted 2017-06-26
Advertisement
Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeFMG
Date Initiated2017-05-30
Date Terminated2024-09-20
Product Quantity304 units
Reason for Recall
The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
Firm Action
Customers were notified via letter on approximately 05/30/2017 and were instructed to examine their inventory, quarantine affected products, complete and return the response form, and return to ICU Medical. If there are any questions or assistance needed, customers can call ICU Customer Service Monday through Friday between 8:30 AM and 4:00 PM Pacific time: 866-829-9025. Or they can email: [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement