Recall Z-2425-2019— Karl Storz Endoscopy

Name: FDA recall Z-2425-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-20

Class II · Terminated

Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2019-02-20, terminated 2020-07-07. It names one FDA 510(k) clearance: K002788. Product: FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1. Reason: The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port..

Recalling firm: Karl Storz Endoscopy
Classification: Class II
Status: Terminated
Initiated: 2019-02-20
Terminated: 2020-07-07
Firm location: El Segundo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K002788 — KSEA NEURO-FIBERSCOPEKARL STORZ Endoscopy-America, Inc.·cleared 2000-10-23

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

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.

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