Z-2425-2019 Class II Terminated

Recalled by Karl Storz Endoscopy — El Segundo, CA

FDA device recall Z-2425-2019 was initiated by Karl Storz Endoscopy on February 20, 2019 and is designated Class II. Reason for recall: The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port. The recall status is terminated (terminated July 7, 2020). Affected quantity: 22 scopes.

Recall Details

Product Type
Devices
Report Date
September 4, 2019
Initiation Date
February 20, 2019
Termination Date
July 7, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22 scopes

Product Description

FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

Reason for Recall

The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

Distribution Pattern

US: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA

Code Information

SERIAL NUMBER: 2161516, 2204079, 2172240, 2198276, 2062041, 2178784, 2198341, 2220959, 2210200, 2183837, 2188370, 2247464, 2248783, 2194154, 2244117, 2039298