Recall Z-2290-2014— Pentax Medical Company

Name: FDA recall Z-2290-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-17

Class II · Terminated

Class II FDA medical device recall by Pentax Medical Company, initiated 2014-07-17, terminated 2015-08-20. It names one FDA 510(k) clearance: K850020. Product: PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve. Reason: The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health..

Recalling firm: Pentax Medical Company
Classification: Class II
Status: Terminated
Initiated: 2014-07-17
Terminated: 2015-08-20
Firm location: Montvale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K850020 — PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23Pentax Precision Instrument Corp.·cleared 1985-07-09

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

PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

Reason for recall

The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.

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