Summary
The FDA issued a Class I for Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110 by C.R. Bard Inc. Reason: Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the ga.
Details
Source
Device Recall
External ID
Z-1757-2025
Action Date
2025-05-28
Status
Ongoing
Category
device
Product Description
Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
Lot/Code Info: All Lots within expiration/UDI: (01)00801741076817
Quantity Affected: N/A
Reason for Recall
Due to customer complaints, there 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.
Distribution
US: 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, Puerto Rico OUS: Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, United Kingdom
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-17
Company
Covington, GA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 147 device recalls issued in the same week, part of 413 device-related FDA actions this month.
C.R. Bard Inc has 78 FDA actions in our database, including 64 recalls and 14 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (C.R. Bard Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does C.R. Bard Inc have FDA actions?
C.R. Bard Inc has 78 FDA actions in our database, including 64 recalls and 14 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1757-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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