UroPass Ureteral Access Sheath
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
UroPass Ureteral Access Sheath |
More than 10 numbers, contact manufacturer. |
61038BX |
Issue
Olympus conducted an investigation after receiving complaints reporting broken dilator tips in the package and in patients during surgical procedures. The investigation showed that reported breakages were associated with devices aged more than three years. Devices manufactured after December 31st, 2019 are not impacted by this recall.
Recall start date: June 5, 2023
Additional information
Details
Gyrus ACMI, Inc.
9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445
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