Recalls / —
—#123294
Product
VersaSafe Extension Set, Model No. 21000M-007
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K944320
- Affected lot / code info
- Lot No. 13066550
Why it was recalled
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.
Root cause (FDA determination)
Employee error
Action the firm took
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.
Recalling firm
- Firm
- CareFusion 303, Inc.
- Address
- 10020 Pacific Mesa Blvd, San Diego, California 92121-4386
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2013-11-08
- Posted by FDA
- 2013-12-03
- Terminated
- 2014-04-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #123294. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.