Bard Blakemore Esophageal-Nasogastric Tube difficult balloon inflation
C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Adult) because users may find it difficult or impossible to remove the plastic plugs needed to inflate the gastric and esophageal balloons.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class I recall. Under the rubric, FDA Class I recalls must score no lower than 4. The inability to inflate balloon components of a medical device used to manage esophageal conditions presents a risk of serious harm, meeting the Severe threshold.
Plain-English summary
C.R. Bard Inc is recalling the Bard Blakemore Esophageal-Nasogastric Tube (Adult), REF: 0092100, due to customer complaints. The issue is a potential difficulty or inability for users to remove the plastic plugs required to inflate the gastric and esophageal balloons.
The recall affects all lots within expiration with UDI (01)00801741076800. The product has been distributed across the United States (including all 50 states and Washington D.C., as well as Puerto Rico) and internationally to Canada, Singapore, Belgium, Ireland, Netherlands, South Africa, Sweden, and the United Kingdom.
Healthcare facilities and distributors who have this product should contact C.R. Bard Inc for instructions on return or replacement. Any users or patients who have received this device should consult with their healthcare provider.
The recalled product
- Product
- Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
- Manufacturer
- C.R. Bard Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots within expiration/UDI: (01)00801741076800
Distribution
Part of a larger recall action
This product is one of 5 recalled by C.R. Bard Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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