Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1756-2025Class I

Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100

C.R. Bard Inc / initiated 2025-04-17 / Open, Classified / root cause: design

C.R. Bard Inc began a recall of Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100 on . FDA classified it as Class I and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-1756-2025
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
C.R. Bard Inc
Product
Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
Product code
KNT Tubes, Gastrointestinal (And Accessories)
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.
Root cause tag
design
FDA root cause
Device Design
Action
On April 17, 2025, BD (C.R. Bard) Urology and Critical Care issued a "Urgent Medical Device Correction" Notification to affected consignees. BD asked consignees to take the following actions: 1. Follow the above plastic plug removal instructions. 2. Post this notice where the devices are stored. 3. Please check all inventory locations within your institution for affected products 4. Share this notice with any users of the product within your facilities or with any interfacility users where product was transferred 5.Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of this notification 6.Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088)
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
Product codes and lots
All Lots within expiration/UDI: (01)00801741076800

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1756-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1755-2025Class IOngoingVoluntary: Firm initiated
Z-1756-2025Class IOngoingVoluntary: Firm initiated
Z-1757-2025Class IOngoingVoluntary: Firm initiated
Z-1758-2025Class IOngoingVoluntary: Firm initiated
Z-1759-2025Class IOngoingVoluntary: Firm initiated