Reported Jul 17, 2013 · Terminated
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston…
Boston Scientific Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material
- Number (UPN) M00554510 Product UsageThe Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia
- Lot codes and dates
- Lot/Batch Number091541
- Amount recalled
- 91
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Product labeled with incorrect expiration date.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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