FDA Device recall Z-0446-2016
Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK…
- FDA Device
- Class II
- terminated
- Published 2015-12-23
On 2015-12-23 the FDA classified a Class II recall of Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK… by Edwards Lifesciences, citing edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0446-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-13 |
| Published | 2015-12-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Edwards Lifesciences |
| Distribution | n/a |
Product
Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
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.
Identifiers
| code_info | 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 60062124 59736951…59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 60062124 59736951 59682161 59682161 59727259 59727259 59727259 59391951 59391951 59391951 59391951 59391951 59407670 59407670 59407670 59407670 59407670 59407670 59407670 59464977 59464977 59464977 59464977 59464977 59464977 59474664 59474664 59474664 59474664 59481176 59481176 59523673 59523673 59523673 59523673 59523673 59540977 59540977 59540977 59540977 59540977 59566031 59566031 59566031 59566031 59566031 59579648 59579648 59579648 59579648 59612801 59612801 59612801 59612801 59612801 59642070 59642070 59642070 59642070 59642070 59752540 59752540 59752540 59752540 59752541 59752541 59752541 59752541 59752541 59752541 59752542 59752542 59752542 59752542 59752542 59766776 59766776 59766776 59766776 59800860 59800860 59800860 59800860 59853819 59853819 59853819 59853819 59876072 59876072 59876072 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0446-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.