PlainRecalls
FDA Devices Moderate Class II Terminated

Flexible Intubation Fiberscope, Model # 11301AB1

Reported: September 11, 2019 Initiated: April 24, 2019 #Z-2447-2019

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.

Details

Recalling Firm
Karl Storz Endoscopy
Units Affected
14 scopes
Distribution
US: VA, MO, CA, OH, NM, NY, CO, LA, ME, OUS: Canada
Location
El Segundo, CA

Frequently Asked Questions

What product was recalled?
Flexible Intubation Fiberscope, Model # 11301AB1. Recalled by Karl Storz Endoscopy. Units affected: 14 scopes.
Why was this product recalled?
The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 11, 2019. Severity: Moderate. Recall number: Z-2447-2019.