Z-1755-2025Class I

Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm)...

Name: Z-1755-2025 Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm)...
Creator: C.R. Bard Inc
Published: 2025-04-17
License: https://open.fda.gov/license/

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

FDA source

C.R. Bard Inc began a recall of Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber on 2025-04-17. 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 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1755-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-04-17
Posted: 2025-05-20
Recalling firm: C.R. Bard Inc
Product: Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
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)00801741076824

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1755-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1755-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-20
Z-1756-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-20
Z-1757-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-20
Z-1758-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-20
Z-1759-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-20

Product code KNT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)