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Terminated

133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: 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). Each set will be manufactured to a unique specifications using dimensions, components and configurations specified by the customer.

FDA Recall Z-0980-2017 · Posted 2017-01-10

Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeFMG
Date Initiated2016-11-30
Date Terminated2017-06-23
Product Quantity225 units

Reason for Recall

ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.

Firm Action

An Urgent Medical Device Recall Notification letter dated 11/30/16 was sent to their customers to inform them that ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber. The letter instructs the customers of the actions required and to return completed recall response form to ICU Medical via fax (801) 264-1755 or by email [email protected]. Customers with questions are instructed to contact ICU Customer Service Monday through Friday between 8:30AM and 4PM Pacific Time, (866) 829-9025 and select option 2 or email [email protected].

Root Cause

Mixed-up of materials/components

Distribution Pattern

US: NC

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.

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