FDA-Device2013-07-17Class III
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
Boston Scientific Corporation
Hazard
Product labeled with incorrect expiration date.
Sold states
Worldwide Distribution - USA Nationwide including the state of NY, NE, MD, OH, TX, PA, VA, PR, CA, NJ, NY, CA and the countries of: AT, FR, DE, GB, IL, IT, LB, NL, ES, SE, TN, Argentina, and Japan.
Affected count
91
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1671-2013Don't want to check this manually?
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