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.
Reported: July 17, 2013 Initiated: May 28, 2013 #Z-1671-2013
Product Description
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.
Reason for Recall
Product labeled with incorrect expiration date.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 91
- Distribution
- 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.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boston Scientific Corporation. Units affected: 91.
Why was this product recalled? ▼
Product labeled with incorrect expiration date.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 17, 2013. Severity: Low. Recall number: Z-1671-2013.
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