FDA recall Z-1848-2019
Stryker GmbH · Class II · device
Product
Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
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-1848-2019