—#140321

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.

FDA product code: FEQ — Pump, Air, Non-Manual, For Endoscope
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K100899
Affected lot / code info: Models: Part number K10016901 is a package of 10 pieces, Part number K10007072 is a package of 100 pieces Part number K10016901: lot numbers 20115441, 20116536, Part number K10007072: lot numbers 20115441, 20116536

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: PO Box 610, 3500 Corporate Pkwy Center, Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US (nationwide) and Canada.

Timeline

Recall initiated: 2015-09-11
Posted by FDA: 2015-10-08
Terminated: 2017-03-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140321. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.