Recall Z-2025-2014 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
| Date | Jul 9, 2014 (initiated Jun 17, 2014) |
| Status | Terminated |
| Reason | CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip c |
| Root cause | Labeling Change Control |
| Action | A recall letter is dated 6/25/14 and will be sent out to customers who purchased the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip chamber. The letter informs the customers of the problems identified, potential risk, and actions to be taken. Customers are instructed to pro |
| Quantity | 5,600 units |
| Distribution | Distributed in the states of FL, NM, WA, WI, and TX. |
| 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 |