FDA Enforcement
Class I
Ongoing
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
Recall: Z-1759-2025
·
Reported May 28, 2025
Enforcement
- Recall Number
- Z-1759-2025
- Event ID
- 96645
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- C.R. Bard Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 28, 2025
- Initiation Date
- April 17, 2025
- Classification Date
- May 20, 2025
- Address
- 8195 Industrial Blvd Ne, N/A, Covington, GA, 30014-1497, United States
Description
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
Reason
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.
Code Info
All Lots within expiration/UDI: (01)00801741076848
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