FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
- Recall number
- Z-2285-2013
- Recalling firm
- CareFusion 303, Inc.
- Product
- SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
- Status
- Terminated
- Initiated
- 2013-08-30
- Posted
- 2013-09-26
- Terminated
- 2014-04-16
- Reason
- CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.
- Root cause
- Process design
- Action
- A customer letter dated August 30, 2013 will be sent to customers to inform them that CareFusion is recalling the SmartSite Low Sorbing Infusion Set Models 10015048, Lot Numbers 130153883 and 13025342 as a result of a potential for separation at the tubing sleeve below the drip chamber.The letter informs the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers are instructed to complete the customer response form and return the form to CareFusion. Customers are instructed to return recalled products directly to distributors. A distributor letter will also be sent to distributors on 8/30/13 to inform them of the problems identified and the actions to be taken. Distributors are instructed to contact the Customer Support Team, return customer response form, and they are instructed to contact the CareFusion Support Center at 1-800-562-6018 with any questions. .
- Quantity
- 15860 units
- Distribution
- Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI
- Lot, serial or model codes
- Lot Numbers 13015883 and 13025342.
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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