Device product
Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
Z-1758-2025
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 96645
- Status
- Ongoing
- Classification
- Class I
- Quantity
- N/A
- Official record key
device-enforcement:Z-1758-2025
Official wording
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 information: All Lots within expiration/UDI: (01)00801741076831
Distribution pattern: 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
Derived failure modes
-
Unknown
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.