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
Reported: May 31, 2023 Initiated: March 31, 2023 #Z-1616-2023
Product Description
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
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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 1297 (Boxes; 5 per Box)
- Distribution
- Natiowide Foreign: Canada, Germany
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Olympus Corporation of the Americas. Units affected: 1297 (Boxes; 5 per Box).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2023. Severity: Low. Recall number: Z-1616-2023.
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