Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or ca
FDA device recall Z-0445-2016 · posted 2015-12-17 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.
- Action taken
- An urgent recall letter dated 11/6/15 will be sent to all customers who purchased the Alaris Pump Module SmartSite Infusion Set because CareFusion has received reports of breakage of the spin collar on the male luer. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed recall response card. Customers with questions related to recall 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, customer feedback@carefusion, 24 hrs/day, 7days/wk.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 1,445,180 units
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, and New Zealand.
- Date initiated
- 2015-11-05
- Date posted
- 2015-12-17
- Date terminated
- 2017-03-01
- Location
- San Diego, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VENTED/NON-VENTED GEMINI ADMINISTRATION SET (K944320) | Imed Corp. | 1995-02-14 |