FDA-Device2013-07-10Class II

- Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429 Manual surgical instrument for general use

Surgical Instrument Service And Savings, Inc.
Hazard

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Sold states
Nationwide Distribution.
Affected count
4
Manufactured in
2747 Sw 6th St, N/A, Redmond, OR, United States
Products
- Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429 Manual surgical instrument for general use

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1639-2013

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