SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
FDA device recall Z-2285-2013 · posted 2013-09-26 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- 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.
- Action taken
- 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. .
- Root cause
- Process design
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 15860 units
- Distribution
- Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI
- Date initiated
- 2013-08-30
- Date posted
- 2013-09-26
- Date terminated
- 2014-04-16
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VENTED/NON-VENTED GEMINI ADMINISTRATION SET (K944320) | Imed Corp. | 1995-02-14 |