Recall Z-1848-2019

Stryker GmbH · initiated April 30, 2019

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1

Codes / lots: Lot # 01410

Reason for recall

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

FDA-determined cause: Under Investigation by firm

Action taken

Urgent Medical Device Recall notification letters dated 4/30/19 were sent to customers.

Details

Recall number
Z-1848-2019
Initiated
April 30, 2019
Terminated
September 18, 2020
Product code
HRX – Arthroscope
Quantity
447
Distribution
The products were distributed US nationwide.
Recalling firm
Stryker GmbH, Selzach

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1849-2019 Class IIEndotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1The seal integrity of the sterile bag containing the kits may be compromised. 04/30/2019Terminated