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.
FDA Recall Z-0113-2016 · Posted 2015-10-08
Advertisement
Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeFEQ
Date Initiated2015-09-11
Date Terminated2017-03-13
Product Quantity31060
Reason for Recall
small puncture marks in a sterile package for an accessory to an Olympus device
Firm Action
A letter of urgent device safety information, dated September 18, 2015, was sent to direct customers to inform them of the issue and instructions to cease use immediately. Customers were also asked to return the completed response form along with affected devices.
Root Cause
Process control
Distribution Pattern
US (nationwide) and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement