Recall Z-1835-2016— Pentax Medical Company

Name: FDA recall Z-1835-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-22

Class II · Terminated

Class II FDA medical device recall by Pentax Medical Company, initiated 2016-02-22, terminated 2017-12-06. It names one FDA 510(k) clearance: K092770. Product: Video Duodenoscope. Reason: Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility..

Recalling firm: Pentax Medical Company
Classification: Class II
Status: Terminated
Initiated: 2016-02-22
Terminated: 2017-12-06
Firm location: Montvale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K092770 — SIMPLYGO HANDS FREE BREAST PUMPEvenflo Company, Inc.·cleared 2009-10-09

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

Video Duodenoscope

Reason for recall

Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.

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