Reported Jul 17, 2024 · Ongoing
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
- Lot codes and dates
Model No. ASX9/130UDI# 00850002332278Lot No. 7336314
- Amount recalled
- 14 units
Where it was sold
Why it was recalled
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
This product could cause temporary or reversible health problems — stop using it.
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