Recall Z-1849-2019— Stryker GmbH

Name: FDA recall Z-1849-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-30

Class II · Terminated

Class II FDA medical device recall by Stryker GmbH, initiated 2019-04-30, terminated 2020-09-18. It names one FDA 510(k) clearance: K922391. Product: Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1. Reason: The seal integrity of the sterile bag containing the kits may be compromised..

Recalling firm: Stryker GmbH
Classification: Class II
Status: Terminated
Initiated: 2019-04-30
Terminated: 2020-09-18
Firm location: Selzach, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K922391 — ENDOSCOPIC CARPAL TUNNEL INSTRUMENTSInstratek, Inc.·cleared 1992-08-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.