FDA Device recall Z-1320-2014
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO
- FDA Device
- Class II
- terminated
- Published 2014-04-09
On 2014-04-09 the FDA classified a Class II recall of Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO by Merit Medical Systems, citing the products are labeled as sterile but were not sterilized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1320-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-13 |
| Published | 2014-04-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Reason
The products are labeled as sterile but were not sterilized.
Identifiers
| code_info | Lot Number H574228 |
|---|
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-1320-2014%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.