RigiflexTM 11 Single-Use Achalasia Balloon Dilator recall
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II…
Why was RigiflexTM 11 Single-Use Achalasia Balloon Dilator recalled?
Product labeled with incorrect expiration date.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot/Batch Number: 091541
- Product
- RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 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.
- Recall date
- July 17, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)