Bard Single Intragastric Linton Balloon Tube difficult plastic plug removal
C.R. Bard Inc is recalling the Bard Single Intragastric Linton Balloon Tube (REF: 0092740) because users may be unable or find it difficult to remove 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 as Class I. Under the rubric, FDA Class I recalls must score at least 4 (Severe or Critical). No deaths or reported illnesses are documented in the source, so the score is 4 (Severe) rather than 5.
Plain-English summary
C.R. Bard Inc is recalling the Bard Single Intragastric Linton Balloon Tube (REF: 0092740) due to a potential defect reported by customers. Users may be unable to remove or find it difficult to remove the plastic plugs that are necessary to inflate the gastric and/or esophageal balloons.
This medical device is used for gastric and esophageal balloon placement and requires proper plug removal for operation. If the plugs cannot be removed as intended, the device cannot function correctly.
The affected product has been distributed throughout the United States, Puerto Rico, and internationally to Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, and the United Kingdom. All lots within expiration are affected (UDI: 00801741076848).
Users with this device should contact C.R. Bard Inc for further instructions regarding this recall.
The recalled product
- Product
- Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
- Manufacturer
- C.R. Bard Inc
- Hazard
- device-malfunction
- difficult-removal
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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