Recalls / —
—#151614
Product
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 product code
- FMG — Stopcock, I.V. Set
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K964435
- Affected lot / code info
- Lot No. 3323650
Why it was recalled
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.
Root cause (FDA determination)
Mixed-up of materials/components
Action the firm took
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 recall@icumed.com. 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 productreturns@icumed.com.
Recalling firm
- Firm
- ICU Medical, Inc.
- Address
- 951 Calle, Amanecer San Clemente, California 92673-6212
Distribution
- Distribution pattern
- US: NC
Timeline
- Recall initiated
- 2016-11-30
- Posted by FDA
- 2017-01-10
- Terminated
- 2017-06-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #151614. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.