Bard Blakemore Child Esophageal-Nasogastric Tube Difficult Plug Removal Prevents Balloon Inflation
C.R. Bard is recalling Blakemore child esophageal-nasogastric tubes due to customer reports of difficulty removing plastic plugs needed to inflate the 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: FDA Class I medical device recall with reported customer complaints of device malfunction. Per recall severity rules, FDA Class I recalls score minimum 4. No reported deaths or serious injuries in source.
Plain-English summary
C.R. Bard Inc is recalling the Bard® Blakemore Esophageal-Nasogastric Tube (Child), Reference 0092110, due to customer complaints indicating difficulty or inability to remove plastic plugs required to inflate the gastric and esophageal balloons on the device.
The affected device was distributed throughout the United States and internationally to Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, and the United Kingdom. All product lots within their expiration date with UDI (01)00801741076817 are subject to this recall.
The plastic plugs must be removed to allow proper inflation of the gastric and esophageal balloons. If the plugs cannot be removed or are difficult to remove, the balloons cannot inflate, and the device cannot function as intended.
Healthcare providers and facilities should contact C.R. Bard Inc and the FDA for instructions on managing affected inventory and obtaining replacement devices. Any adverse events or complications associated with this device should be reported to the FDA.
The recalled product
- Product
- Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
- 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)00801741076817
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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