SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserte
FDA device recall Z-0221-2016 · posted 2015-11-05 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
- Action taken
- An urgent medical device recall notification was sent to customers on 10/9/15 who purchased the SmartSite Extension Set. The letter informs the customers that CareFusion has identified potential risks with model code 20029E, lot numbers 1503541, 15015769 and 15045950 due to disconnection and leakage issues. The letter also provides the customers with the potential risk involved and the actions to be taken. Customers are instructed to complete and return to CareFusion the recall response card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266 or email customerfeedback@carefusion.com. Customers with technical questions regarding technical questions are instructed to contact Technical Support at (888) 812-3229.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 21,000 units
- Distribution
- Distributed US (nationwide) and in Canada.
- Date initiated
- 2015-10-09
- Date posted
- 2015-11-05
- Date terminated
- 2017-03-02
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IVAC NEEDLE FREE VALVE ADMINISTRATION SETS (K960280) | Y | 1996-04-04 |