127" (323cm) Transfer Set w/Check Valve, MicroClave… recallZ-1593-2015 · ICU Medical, Inc. · initiated Apr 20, 2015
Class II Terminated All recalls posted in May 2015
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 is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
FDA root cause category: Under Investigation by firm
What the company is doing
An Urgent Medical Device Recall letter dated 4/17/15 will be sent to customers on 4/20/15 to inform them that ICU Medical Inc. has identified a potential connection separation issue in a small number of isolated Intravenous Administration Transfer Sets. While the separation may be visually detected, if used, this failure mode could lead to leakage. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to return completed recall response form to ICU Medical by Fax at (801) 264-1755 or email to [email protected]. Customers with questions or require assistance relating to the recall are instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: [email protected].
Recall details
- Recall number
- Z-1593-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 20, 2015
- Posted by the FDA
- May 7, 2015
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 5,100 units
- Product code
- FMG
- FDA submissions
- K964435
- Distribution
- Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN
Product description
127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Code information (models, lots, serial numbers)
Lot No. 2997914 2997918 2998570 3001230 3001231
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 71028).
- Z-1588-2015 · Terminated119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing,…
- Z-1589-2015 · Terminated107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the i…
- Z-1590-2015 · Terminated104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubi…
- Z-1591-2015 · Terminated113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP …
- Z-1592-2015 · Terminated108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326
- Z-1594-2015 · Terminated98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage: IV…
- Z-1595-2015 · Terminated98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Product Usage: IV Administration sets are intended for the infusion …
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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