SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion
FDA device recall Z-0450-2014 · posted 2013-12-04 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.
- Action taken
- The firm, CareFusion, sent an "URGENT: Medical Device Recall Notification" letter dated November 8, 2013 to all customers who purchased the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card and return all recalled product directly to the distributor form whom it was purchased. Customers with questions are instructed to contact their distributor directly or call the CareFusion Support Center at (888) 562-6018. If you have recall related questions or need support, please call CareFusion Support Center at 1-888-562-6018; hours: 7am to 4pm PST or Technical Support at 1-888-812-3229; hours 7am to 5pm PST.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 480 units
- Distribution
- US Distribution in CA, WY, OH, UT, and MA.
- Date initiated
- 2013-11-08
- Date posted
- 2013-12-04
- Date terminated
- 2014-05-27
- 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 |