Recall Z-0435-2014 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
VersaSafe Extension Set, Model No. 21000M-007
| Date | Dec 3, 2013 (initiated Nov 8, 2013) |
| Status | Terminated |
| Reason | 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 | Employee error |
| Action | 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. |
| Quantity | 3500 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944320 | VENTED/NON-VENTED GEMINI ADMINISTRATION SET Imed Corp., Feb 14, 1995 |