Reported Nov 16, 2016 · Terminated
ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape…
Reshape Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Reshape Medical Inc · 100 Calle Iglesia · San Clemente, CA · 92672-7502
Is this the product you have?
- ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No
- RSM110 product UsageThe ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone
- Lot codes and dates
- Lot Number Expiration Date
160815-0012018-08-07160816-0012018-08-07160824-0032018-08-18160825-0012018-08-18160825-0022018-08-18
- Lot Number Expiration Date
- Amount recalled
- 114 units
Where it was sold
Why it was recalled
ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.
This product could cause temporary or reversible health problems — stop using it.
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