FDA recall Z-1557-2022

Product

Echelon -14 Micro Catheter, REF: 105-5092-150, 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-1557-2022