FDA recall Z-2447-2019

Product

Flexible Intubation Fiberscope, Model # 11301AB1

Reason for recall

The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.

Distribution

US: VA, MO, CA, OH, NM, NY, CO, LA, ME, OUS: Canada

Key facts

Status

Terminated

Initiation date

2019-04-24

Report date

2019-09-11

Termination date

2020-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

El Segundo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2447-2019