Recall Z-0446-2016 ยท DXO Transducer, Pressure, Catheter Tip
Edwards Lifesciences, LLC
Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
| Date | Nov 13, 2015 |
| Status | Terminated |
| Reason | Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices. |
| Root cause | Under Investigation by firm |
| Action | An urgent product notification letter dated 11/13/15 was to customers to inform them that during an internal documentation review, the requirement of an additional FDA submission to support commercialization (clearance) of the devices was discovered. Customers are informed that the Edwards Lifesciences Intravascular (IV) Administration sets are temporarily unavailable for sale. Customers are informed that there is no increased risk to the patients' health or safety by using products in their current inventory and there is no impact to the IV sets included in pressure monitoring kits (with Tr |
| Quantity | 147,350 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.