UroPass Ureteral Access Sheaths, 5 pieces/box
Reported: August 23, 2023 Initiated: May 19, 2023 #Z-2401-2023
Product Description
UroPass Ureteral Access Sheaths, 5 pieces/box
Reason for Recall
Dilator tips may break in the package and in patients during surgical procedures.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 9520 eaches
- Distribution
- Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
UroPass Ureteral Access Sheaths, 5 pieces/box. Recalled by Olympus Corporation of the Americas. Units affected: 9520 eaches.
Why was this product recalled? ▼
Dilator tips may break in the package and in patients during surgical procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 23, 2023. Severity: Moderate. Recall number: Z-2401-2023.
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