Surgical Instrument Service And Savings Recalls Relieva Flex Sinus Guide Catheter
Surgical Instrument Service And Savings, Inc. is recalling Relieva Flex Sinus Guide Catheter and Luma Sentry 20 Tip Angle products because the sterile barrier seal may be compromised.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of sterility without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling specific lots of Relieva Flex Sinus Guide Catheter and Relieva Luma Sentry 20 Tip Angle products. The recall involves 4 units of these manual surgical instruments, which were distributed nationwide.
The recall was initiated because the seal that maintains a sterile barrier for these reprocessed medical devices became compromised. This defect may allow the product to fall out of the pouch, potentially compromising sterility.
Healthcare facilities and consumers should stop using the affected products and contact the recalling firm for instructions on return or replacement.
The recalled product
- 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
- Surgical Instrument Service And Savings, Inc.
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 122429
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Surgical Instrument Service And Savings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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