Bard Minnesota Four Lumen Esophagogastric Tamponade Tube Recalled
C.R. Bard Inc is recalling the Bard Minnesota Four Lumen Esophagogastric Tamponade Tube (REF:0092220) because users may be unable to or have difficulty removing 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 classified this recall as Class I, which per the rubric requires a minimum score of 4. The device dysfunction (inability to inflate balloons) creates risk of harm in a clinical setting where this esophagogastric tamponade tube is used in emergency hemorrhage management.
Plain-English summary
C.R. Bard Inc is recalling the Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220, 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber. The recall was initiated due to customer complaints.
The issue 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. This may prevent the device from functioning as intended.
The affected device has been distributed throughout the United States (including all 50 states and Washington, D.C.), Puerto Rico, and internationally to Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, and the United Kingdom. All lots within expiration are affected, identified by UDI (01)00801741076824.
Patients and healthcare providers who have this device should contact C.R. Bard Inc for instructions on how to proceed. The FDA has classified this as a Class I recall.
The recalled product
- Product
- Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
- 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)00801741076824
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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