—#199755

Product

To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A

FDA product code: FCG — Biopsy Needle
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K160098
Affected lot / code info: UDI: 04953170388286 Lot numbers: KR248740 KR248746 KR252863 KR253666 KR253681 KR260854 KR260865 KR260873 KR260875 KR260876 KR260877 KR260896 KR260917 KR260937

Why it was recalled

Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.

Root cause (FDA determination)

Employee error

Action the firm took

Olympus issued Urgent Medical Medical Device Recall letter on 3/31/23 to Endoscopy Department, Pulmonology Department; Risk Management. . Letter states reason for recall, health risk and action to take: 1. Immediately locate any affected products listed in this communication and quarantine these products. 2. Contact our Olympus Customer Service Team at 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility upon return of affected product. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. " Go to https://olympusamerica.com/recall and enter the recall number 0422 4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Olympus requests that you report complaints, including patient injuries and adverse events, to Olympus. Please report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, to report complaints

Recalling firm

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

Distribution

Distribution pattern: Natiowide Foreign: Canada, Germany

Timeline

Recall initiated: 2023-03-31
Posted by FDA: 2023-05-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199755. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.