FDA recall Z-1556-2022

Micro Therapeutics, Inc. · Class II · device

Product

Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only

Reason for recall

Outer carton packaging of microcatheters were exposed to wet substance during transport.

Distribution

US Nationwide Distribution: None OUS: Brazil

Key facts

Status: Ongoing
Initiation date: 2022-06-30
Report date: 2022-08-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1556-2022