Z-0392-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 16, 2016
- Initiation Date
- October 14, 2016
- Termination Date
- January 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114 units
Product Description
ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The 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.
Reason for Recall
ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.
Distribution Pattern
US Nationwide Distribution in the states of: MO, TX, AZ, CA, NY, TN, GA, LA, FL, MA, OH, IN, IL
Code Information
Lot Number Expiration Date 160815-001 2018-08-07 160816-001 2018-08-07 160824-003 2018-08-18 160825-001 2018-08-18 160825-002 2018-08-18