18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave… recallZ-2716-2017 · ICU Medical, Inc. · initiated May 30, 2017
Class II Terminated All recalls posted in June 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
The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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].
Recall details
- Recall number
- Z-2716-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 30, 2017
- Posted by the FDA
- Jun 26, 2017
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 304 units
- Product code
- FMG
- FDA submissions
- K964435
- Distribution
- Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
Product description
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).
Code information (models, lots, serial numbers)
Lot No. 3172948, 3192947, 3224228, 3246765, 3260270. Item No. 011-AM6111
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
Other products in the same recall event
The FDA groups related products into one recall event (event 77560).
- Z-2717-2017 · Terminated168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, Rotating Luer. Product Usage: The device is a single use, sterile,…
- Z-2718-2017 · Terminated28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device whic…
- Z-2719-2017 · Terminated28 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 whi…
- Z-2720-2017 · TerminatedPROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-…
- Z-2721-2017 · TerminatedKit w/3 Ext Sets, 3 Drop-In MicroClave Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from …
- Z-2722-2017 · Terminated10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile,…
- Z-2723-2017 · Terminated10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides acce…
- Z-2724-2017 · Terminated10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a s…
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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