FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: 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
- Recall number
- Z-1482-2017
- Recalling firm
- CareFusion 303, Inc.
- 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
- Status
- Terminated
- Initiated
- 2017-02-20
- Posted
- 2017-02-28
- Terminated
- 2018-10-29
- Reason
- CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.
- Root cause
- Under Investigation by firm
- Action
- CareFusion sent an Urgent Medical Device Recall Notification letter dated February 2017 to all affected customers inform them that CareFusion is recalling the MaxGuard Extension Set model codes ME20164, MP9009-C, MP9209, MP9254-C with multiple lot numbers. CareFusion has received reports of leaks occurring with the 0.2 micron filter. Customers were informed that leakages on an extension can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, underinfusion or air in line. Customers were instructed to discontinue use of the affected product and contact CareFusion for a replacement lot. The letter informs the customers of the actions to be taken and for recall related questions to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266. Customers were also instructed to immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card.
- Quantity
- 12,850 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot No. 15045419 15075822 15086644 16036290 16056204 16075270 15086404 16067461 16046571 16045810
- 510(k) numbers
- ["K051499"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2016493
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28