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Bard Blakemore Esophageal-Nasogastric Tube recallZ-1756-2025 · C.R. Bard Inc · initiated Apr 17, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from C.R. Bard Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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)

Recall details

Recall number
Z-1756-2025
Status
Open, Classified
Initiated by the company
Apr 17, 2025
Posted by the FDA
May 20, 2025
Recalling firm
C.R. Bard Inc
Product code
KNT
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 description

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

Code information (models, lots, serial numbers)

All Lots within expiration/UDI: (01)00801741076800

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96645).

Sources and updates

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