Device product
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
Z-1006-2026
Product summary
- Event
- Event 98068
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-1006-2026
Official wording
Reason: Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Code information: UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
Distribution pattern: US Nationwide distribution in the state of WA.
Derived failure modes
-
Unknown
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.