133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2… recallZ-0980-2017 · ICU Medical, Inc. · initiated Nov 30, 2016
Class II Terminated All recalls posted in January 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ICU Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Mixed-up of materials/components
What the company is doing
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].
Recall details
- Recall number
- Z-0980-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 30, 2016
- Posted by the FDA
- Jan 10, 2017
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 225 units
- Product code
- FMG
- FDA submissions
- K964435
- Distribution
- US: NC
Product description
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.
Code information (models, lots, serial numbers)
Lot No. 3323650
Other devices under the same FDA submission
563 devices cleared under K964435 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
- ICU Medical B90111Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical B9535Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical B9650Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical Z3239Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical Z3626Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical MRSA60-84Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical AM3020Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical B33971Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical B3065Icu Medical, Inc. · Stopcock, i.V. Set1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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