HIGH

Cardinal Health Recalls Salem Sump PVC Tubes Due to Breakage Risk

Cardinal Health 200 recalled Salem Sump PVC gastroduodenal tubes on September 18, 2025. The recall affects all lots sold worldwide due to complaints of Anti-Reflux Valve breakage. Patients and healthcare providers must stop using the devices immediately.

Quick Facts at a Glance

Recall Date
September 18, 2025
Hazard Level
HIGH
Brand
Cardinal Health 200
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cardinal Health 200, LLC or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recall includes various Salem Sump PVC and polyurethane gastroduodenal tubes in multiple sizes. The affected product codes include 1180264408, 1180264416, 1180264424, 1180264432, 1180264440, 1180264457, 1180264523, 1180264531, 1180264549, 1180264556, and 1180264895. These products were distributed worldwide.

The Hazard

The firm received complaints concerning the breakage of the Anti-Reflux Valve (ARV) when excessive force is applied during use. This poses a high risk of improper function leading to complications in patients.

Reported Incidents

While the exact number of incidents is not disclosed, complaints regarding ARV breakage have prompted this urgent recall. There are no reported injuries or deaths associated with this issue.

What to Do

Patients and healthcare providers should stop using the affected tubes immediately and follow the recall instructions provided by Cardinal Health. Contact the company or your healthcare provider for guidance.

Contact Information

For more information, contact Cardinal Health at [insert phone number] or visit their website [insert URL].

Key Facts

  • Product Code/Product Name/UDI-DI: 1180264408 to 8888264887
  • Class II recall
  • Stop using the device immediately
  • Notification via letter
  • Worldwide distribution including the US

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Product Code/Product Name/UDI-DI: 1180264408 Salem Sump" PVC Gastroduodenal Tube
10 Fr/Ch (3.3 mm) x 90 cm 10192253006940 1180264416 Salem Sump" PVC Gastroduodenal Tube
12 Fr/Ch (4.0 mm) x 114 cm 10192253006957 1180264424 Salem Sump" PVC Gastroduodenal Tube
14 Fr/Ch (4.7 mm) x 114 cm 10192253006964 1180264432 Salem Sump" PVC Gastroduodenal Tube
16 Fr/Ch (5.3 mm) x 114 cm 10192253006971 1180264440 Salem Sump" PVC Gastroduodenal Tube
+15 more
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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