FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
- Recall number
- Z-1464-2017
- Recalling firm
- CareFusion 303, Inc.
- Product
- MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
- Status
- Terminated
- Initiated
- 2017-02-20
- Posted
- 2017-02-28
- Terminated
- 2017-11-17
- Reason
- CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.
- Root cause
- Process control
- Action
- An Urgent Medical Device Recall Notification letter will be sent to customers on February 20, 2017 to inform them that CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter model number ME3305 Lot Number 16016790. Customers are informed that CareFusion has received reports of separation and/or leakages between theY-connector and tubing. Customers are informed that leakages from an extension set can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, or underinfusion. 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.
- Quantity
- 1,200 units
- Distribution
- US Distribution including MA and MD
- Lot, serial or model codes
- Lot No. 16016790
- 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