MaxGuard Extension Set — Class II medical device recall Z-1482-2017
Terminated recall by CareFusion 303, Inc., reported 2017-03-22, distributed nationwide. CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filte
| Recall number | Z-1482-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2017-02-20 |
| Classified | 2017-03-16 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2018-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 12,850 units |
| Reason classes | packaging |
| Lot numbers | 15045419, 15075822, 15086404, 15086644, 16036290, 16045810, 16046571, 16056204, 16067461, 16075270 |
| Model numbers | ME2064, MP9009C, MP9209, MP9254C |
Product
MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets
Reason for recall
CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.