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Single Use Aspiration Needle NA-U401SX recallZ-1615-2023 · Olympus Corporation of the Americas · initiated Mar 31, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Employee error

What the company is doing

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

Recall details

Recall number
Z-1615-2023
Status
Open, Classified
Initiated by the company
Mar 31, 2023
Posted by the FDA
May 19, 2023
Recalling firm
Olympus Corporation of the Americas
Quantity
2058 (Boxes; 5 per Box)
Product code
FCG
FDA submissions
K160098
Distribution
Natiowide Foreign: Canada, Germany

Product description

ViziShot 2 Single Use Aspiration Needle, 21G- 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. Model: NA-U401SX-4021, NA-U401SX-4021-A

Code information (models, lots, serial numbers)

UDI: 04953170388248 Lot numbers: KR243729 KR248648 KR248652 KR248673 KR248784 KR248785 KR248808 KR249160 KR251593 KR257313 KR257314 KR264662 KR264697 KR264708 KR264711 KR264726 KR264732 KR264746 KR264751 KR264778 KR264806 KR276770

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K160098 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92129).

Sources and updates

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