Medical Device Recall: Z-0029-2012

FDA Recalls dataset · Firm: Olympus America Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2011-08-25 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0029-2012.

Recall Res Number
Z-0029-2012
Recalling Firm / Manufacturer
Olympus America Inc.
FEI Number
2429304
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2011-08-25
Date Posted
2011-10-07
Date Terminated
2012-09-28
Product Code
FCG
Event Number
59787
Product Quantity
22,498
Product Description 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.
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
Action Details 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.
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.
Code Information / Serial Numbers Models: NA-201SX-4022-A --22 gauge needle: all lot numbers; NA-201SX-4022-B --22 gauge needle: all lot numbers; NA-201SX-4022-C --22 gauge needle: all lot numbers; and NA-201SX-4021 -- 21 gauge needle: all lot numbers.

Related Establishments / Registrations

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