ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle as

FDA device recall Z-1615-2023 · posted 2023-05-19 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

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.

Action taken

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

Root cause

Employee error

Status

Open, Classified

Product code

FCG

Quantity affected

2058 (Boxes; 5 per Box)

Distribution

Natiowide Foreign: Canada, Germany

Date initiated

2023-03-31

Date posted

2023-05-19

Location

Center Valley, PA

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