Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Reason for recall: Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons. Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico OUS: Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, United Kingdom Quantity: N/A Lot/code info: All Lots within expiration/UDI: (01)00801741076824
00801741076824
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.