SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medi
FDA device recall Z-1053-2015 · posted 2015-02-04 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
- Action taken
- CareFusion sent an Urgent Medical Device Recall Notification letter dated January 13, 2015, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return to CareFusion the recall response card. Customers with questions were instructed to CareFusion: Recall related questions, (888) 562-6018; Adverse Event Reports, (888) 812-3266; Technical Questions regarding the Alaris System, (888) 812-3229.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 7,440 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-01-13
- Date posted
- 2015-02-04
- Date terminated
- 2016-03-15
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IVAC NEEDLE FREE VALVE ADMINISTRATION SETS (K960280) | Y | 1996-04-04 |