Bard Intragastric Linton Balloon Tube Recall Due to Plug Removal Defect
C.R. Bard Inc is recalling the Bard® Single Intragastric Linton Balloon Tube because users may be unable to remove plastic plugs needed to inflate the device's balloons. This is an FDA Class I recall affecting all lots within expiration.
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: This product carries an FDA Class I classification, the most serious category of recall per FDA policy. Although no injuries or illnesses have been reported to date, the functional defect could impair proper device use during critical medical procedures.
Plain-English summary
The Bard® Single Intragastric Linton Balloon Tube (REF: 0092740), manufactured by C.R. Bard Inc, is subject to an FDA Class I recall. This medical device is used to inflate gastric and esophageal balloons in clinical procedures.
Customer complaints reveal that users may have difficulty removing or be unable to remove the plastic plugs that are necessary to inflate the gastric and/or esophageal balloons. This functional defect could prevent proper use of the device during medical procedures.
The product was distributed in all United States, Puerto Rico, and internationally to Singapore, Canada, Belgium, Ireland, the Netherlands, South Africa, Sweden, and the United Kingdom. All lots with the UDI 00801741076848 that are still within their expiration dates are affected.
Patients, healthcare providers, and medical facilities currently using this device should immediately cease use and contact C.R. Bard Inc for additional information or replacement instructions.
The recalled product
- Product
- Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
- Manufacturer
- C.R. Bard Inc
- Hazard
- malfunction
- device-defect
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)00801741076848
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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