SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Reported: January 24, 2024 Initiated: December 4, 2023 #Z-0718-2024
Product Description
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Reason for Recall
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 179 units
- Distribution
- Domestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS KY LA MA MI NC ND NE NJ NY OR PA SC SD TN TX VA WI International distribution to Canada, Latin America, and Europe.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS. Recalled by Olympus Corporation of the Americas. Units affected: 179 units.
Why was this product recalled? ▼
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2024. Severity: Moderate. Recall number: Z-0718-2024.
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