FDA recall Z-1849-2019

Stryker GmbH · Class II · device

Product

Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1

Reason for recall

The seal integrity of the sterile bag containing the kits may be compromised.

Distribution

The products were distributed US nationwide.

Key facts

Status
Terminated
Initiation date
2019-04-30
Report date
2019-06-26
Termination date
2020-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Selzach, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1849-2019