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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- device-malfunction
- plug-removal-difficulty
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
Distributed in 51 states:
- 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
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