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Surgical Instrument Service And Savings, Inc. recalls - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angl
Recalled July 10, 2013 · FDA recall Z-1639-2013 · Surgical Instrument Service And Savings
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. · FDA Class II
Units
4
Sold at
Nationwide Distribution.
Description
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product
- 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
Manufacturer(s)
Surgical Instrument Service And Savings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →