VersaSafe Extension Set, Model No. 21000M-007
FDA device recall Z-0435-2014 · posted 2013-12-03 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.
- Action taken
- A customer letter and a distributor letter will be distributed on 11/8/13 to all customers who purchased the VersaSafe Extension Set, Model 21000M-07, Lot Number 13066550. 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, pre-addressed and postage paid, Recall Response Card.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 3500 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-11-08
- Date posted
- 2013-12-03
- Date terminated
- 2014-04-17
- 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 |