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Terminated

OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

FDA Recall Z-0029-2012 · Posted 2011-10-07

Recalling FirmOlympus America Inc.
Recall StatusTerminated
Product CodeFCG
Date Initiated2011-08-25
Date Terminated2012-09-28
Product Quantity22,498

Reason for Recall

Firm has received complaints from users of the ability to wipe material from the needle's stylet and the presence of material in patient cytology samples obtained by the needle following endobronchial ultrasound fine needle aspiration of a lesion. Olympus Medical Systems Corporation (OMSC) in Japan has confirmed that metal particles can occur on the stylet due to friction between the stylet and n

Firm Action

OLYMPUS sent an URGENT MEDICAL DEVICE CORRECTION letter dated August 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A revised Instruction Manual with the new WARNINGS will be sent to the customer's attention. Customers were instructed to examine their inventory to determine if they have the affected product. To share the information on the new WARNINGS with all of the appropriate staff at their facility and any other organization where the product has been transferred. Complete and return the enclosed questionnaire even if they do not have affected product. Customers were instructed to fax the completed questionnaire to 484-896-7128. For any question call 484-896-5688.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution including the District of Columbia and the following States: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050503SINGLE USE ASPIRATION NEEDLE NA-201SX-4022Olympus Medical Systems Corporation · 2005-05-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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