GA Health Company Recalls Bulldog Disposable Endoscope Valves Due to Defects
GA Health Company is recalling 20,000 units of Bulldog Disposable Endoscope Valves because the suction button is reported sticky or broken, which may cause prolonged 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. The hazard involves a functional defect that may cause prolonged procedures, representing a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GA Health Company Limited is recalling 20,000 units of Bulldog Disposable Endoscope Valves (Product Code 1203-71). The product is manufactured for Diversatek Healthcare. The recall was initiated because the suction button is reported to be sticky and/or broken during or after the procedure, which may cause prolonged procedures.
The affected units are identified by Lot Number 20B10A. The distribution pattern includes US Nationwide distribution, specifically mentioning the states of IL, NY, NJ, WI, and MI. The recall is classified as Class II by the FDA.
Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71
- Manufacturer
- GA HEALTH COMPANY LIMITED
- Affected units
- 20,000
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
FDA (Devices) · 2020-12-30
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