FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
- Recall number
- Z-1179-2016
- Recalling firm
- CareFusion 303, Inc.
- Product
- Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
- Status
- Terminated
- Initiated
- 2016-02-15
- Posted
- not on file
- Terminated
- 2016-10-24
- Reason
- CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.
- Root cause
- Other
- Action
- A customer notification letter dated 2/15/16 will be sent to customers to inform them that CareFusion is recalling the Alaris VersaSafe Infusion set number 2122-0007, Lot number 13085603. The letter informs the customers that Separation or leakage at the VersaSafe split septum port and tubing may lead to leakage of the administration set. The separation and leakage may occur during infusion. The letter informs customers of the potential risk and actions to be taken. Customers with recall related equations are instructed to contact CareFusion Support Center at (888) 562-6018, 7am-4pm PST. Customers with adverse event reports are instructed to contact Customer Advocacy at (888)812-3266, customerfeedback@carefusion.com, 24 hrs/day, 7 days/wk. Customers are instructed to complete and return the enclosed mandatory customer response card to acknowledge the receipt of the customer communication.
- Quantity
- 5,760 units
- Distribution
- Michigan
- Lot, serial or model codes
- Lot No. 13085603
- 510(k) numbers
- ["K944320"]
- 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