Bard Blakemore Esophageal-Nasogastric Tube Intermediate Balloon Inflation Difficulty
C.R. Bard Inc is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Intermediate, REF 0092300) due to reports that plastic plugs may be difficult or impossible to remove, preventing proper inflation of the gastric and/or 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. Per the rubric, FDA Class I recalls are never scored below 4, and this meets the Severe threshold as a Class I medical device recall where the device may fail to function properly.
Plain-English summary
C.R. Bard Inc is recalling the Bard Blakemore Esophageal-Nasogastric Tube (Intermediate), model REF 0092300, due to customer complaints regarding plastic plugs in the device.
The issue is that users may be unable to remove or have difficulty removing the plastic plugs necessary to inflate the gastric and/or esophageal balloons. This could prevent the device from functioning as intended.
The affected product has been distributed throughout the United States, Puerto Rico, and internationally to Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, United Kingdom, and Singapore. The recall covers all lots with UDI (01)00801741076831 that are within expiration dates.
Patients and healthcare providers who have this device in use should contact C.R. Bard Inc or the FDA for instructions on replacement or corrective measures.
The recalled product
- Product
- Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
- 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)00801741076831
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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