GA Health ScopeValet Guardian Disposable Endoscope Valves Recalled for Defects
GA Health Company Limited is recalling ScopeValet Guardian Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect that may prolong medical procedures, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GA Health Company Limited is recalling ScopeValet Guardian Disposable Endoscope Valves, distributed by Ruhof Corporation. The recall involves 100,000 units of the product, identified by Product Code 345SVVO1. The affected lots are 19122414, 20030401, and 20030402.
The recall was initiated because the suction button on the valves is reported to be sticky and/or broken during or after the procedure. This defect may cause the procedure to be prolonged. The product was distributed nationwide in the United States, including in the states of Illinois, New York, New Jersey, Wisconsin, Michigan, and Minnesota.
Healthcare facilities and consumers who have these specific units should stop using them and contact the recalling firm for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
- Manufacturer
- GA HEALTH COMPANY LIMITED
- Affected units
- 100,000
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 (2)
- Lot Numbers: 19122414
- 20030401
Distribution
Part of a larger recall action
This product is one of 11 recalled by GA HEALTH COMPANY LIMITED 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.
See all 11 products in this recall →Related recalls
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- HighGA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button
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- HighGA Health Recalls ScopeValet Guardian Disposable Endoscope Valves Due to Defect
FDA (Devices) · 2020-12-30
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