Recall Z-2447-2019— Karl Storz Endoscopy

Class II · Terminated

Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2019-04-24, terminated 2020-12-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Flexible Intubation Fiberscope, Model # 11301AB1. Reason: The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer..

Recalling firm
Karl Storz Endoscopy
Classification
Class II
Status
Terminated
Initiated
2019-04-24
Terminated
2020-12-04
Firm location
El Segundo, CA, United States

Product description

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.

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