Bard Single Intragastric Linton Balloon Tube, REF: 0092740
- Company
- C.R. Bard, Inc.
- Recall Initiated
- April 17, 2025
- Posted
- May 20, 2025
- Recall Number
- Z-1759-2025
- Firm Location
- Covington, GA
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
Lot / Code Info
All Lots within expiration/UDI: (01)00801741076848
Root Cause
Device Design
Action Taken
On April 17, 2025, BD (C.R. Bard) Urology and Critical Care issued a "Urgent Medical Device Correction" Notification to affected consignees. BD asked consignees to take the following actions: 1. Follow the above plastic plug removal instructions. 2. Post this notice where the devices are stored. 3. Please check all inventory locations within your institution for affected products 4. Share this notice with any users of the product within your facilities or with any interfacility users where product was transferred 5.Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of this notification 6.Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088)