94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300… recallZ-2130-2012 · ICU Medical, Inc. · initiated Apr 17, 2012
Class II Terminated All recalls posted in August 2012
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 firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
FDA root cause category: Nonconforming Material/Component
What the company is doing
ICU Medical sent an Urgent Medical Device Recall letter dated April 2012 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to inspect inventory, destroy affected products according to hospital protocol, complete and return verification form and contact ICU Customer Service to order replacement products. The letter states that ICU Medical will credit customer for any product destroyed once the completed verification form is received. This recall should be carried out to the user level and passed on to all those who need to be aware within your organization or any other organization the device may have been transferred to. Should you have any questions or require assistance relating to this recall please 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-2130-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 17, 2012
- Posted by the FDA
- Aug 2, 2012
- Recalling firm
- ICU Medical, Inc.
- Product code
- FMG
- FDA submissions
- K964435
- Distribution
- Nationwide distribution
Product description
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
Code information (models, lots, serial numbers)
Part Number B30059 510(k) K964435 Lot number 2418897, 2423996, 2425137, 2430044, 2431861, 2436569, 2443559, 2447238, 2448099, 2452377, 2457453, 2459025, 2464569, 2467687.
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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