Bard Blakemore Esophageal-Nasogastric Tube Difficult Plastic Plug Removal
C.R. Bard Inc is recalling Bard Blakemore Esophageal-Nasogastric Tubes due to customer reports of 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: This is an FDA Class I recall, which mandates a minimum severity rating of 4. Although no injuries or deaths have been reported, the recall addresses a critical functional malfunction in a medical device used for treating serious esophageal conditions.
Plain-English summary
The Bard Blakemore Esophageal-Nasogastric Tube (Intermediate) is being recalled by C.R. Bard Inc due to customer complaints that users may have difficulty removing or be unable to remove the plastic plugs required to inflate the gastric and esophageal balloons.
The affected devices include all lots within their expiration date, identified with UDI (01)00801741076831. The tubes have been distributed throughout the United States (all states and Puerto Rico) and internationally to Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, and the United Kingdom.
This is a Class I recall issued by the U.S. Food and Drug Administration. Users and healthcare providers should verify the UDI of any Bard Blakemore Esophageal-Nasogastric Tubes in their possession and contact C.R. Bard Inc or their healthcare provider if they have one of the affected units.
The recalled product
- Product
- Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
- Manufacturer
- C.R. Bard Inc
- Hazard
- device-malfunction
- inflation-failure
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
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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