FDA Device recall Z-0162-2015
Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged
- FDA Device
- Class II
- terminated
- Published 2014-11-12
On 2014-11-12 the FDA classified a Class II recall of Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged by Merit Medical Systems, citing these microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0162-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-26 |
| Published | 2014-11-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
Reason
These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
Identifiers
| code_info | Catalog No: 28MC24130ST, Lot H665694, H669824, Exp 2017 and Catalog No: 28MC24150SN, Lot H665696, Exp 7/31/2014 |
|---|
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-0162-2015%22
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