Recall Z-0113-2016— Olympus Corporation of the Americas

Name: FDA recall Z-0113-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-11

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2015-09-11, terminated 2017-03-13. It names one FDA 510(k) clearance: K100899. Product: MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.. Reason: small puncture marks in a sterile package for an accessory to an Olympus device.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2015-09-11
Terminated: 2017-03-13
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K100899 — OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2Keymed (Medical & Industrial Equipment), Ltd.·cleared 2010-09-13

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

MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.

Reason for recall

small puncture marks in a sterile package for an accessory to an Olympus device

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