🔍 RecallPedia

Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264432 Salem Sump" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 1180264440 Salem Sump" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 1180264457 Salem Sump" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 1180264523 Salem Sump" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264531 Salem Sump" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 1180264549 Salem Sump" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 1180264556 Salem Sump" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 1180264895 Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm 8888264804 Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm 8888264820 Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm 8888264846 Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm 8888264861 Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm 8888264887 Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm SKUs not distributed in US

Class I - Dangerous
🏥 Medical Devices Recalled: September 18, 2025 Cardinal Health 200 Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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, 18 Fr/Ch (6.0 mm) x 114 cm 10192253007053 1180264457 Salem Sump" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 10192253006568 1180264523 Salem Sump" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 10192253007060 1180264531 Salem Sump" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 10192253006988 1180264549 Salem Sump" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 10192253006995 1180264556 Salem Sump" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 10192253007008 1180264895 Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm 10192253007015 8888264804 Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm 10192253012408 8888264820 Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm 10192253012415 8888264846 Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm 10192253012422 8888264861 Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm 10192253012439 8888264887 Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm 10192253012446 All Lots
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cardinal Health 200, LLC
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264432 Salem Sump" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 1180264440 Salem Sump" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 1180264457 Salem Sump" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 1180264523 Salem Sump" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264531 Salem Sump" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 1180264549 Salem Sump" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 1180264556 Salem Sump" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 1180264895 Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm 8888264804 Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm 8888264820 Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm 8888264846 Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm 8888264861 Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm 8888264887 Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm SKUs not distributed in US

Product Codes/Lot 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, 18 Fr/Ch (6.0 mm) x 114 cm 10192253007053 1180264457 Salem Sump" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 10192253006568 1180264523 Salem Sump" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 10192253007060 1180264531 Salem Sump" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 10192253006988 1180264549 Salem Sump" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 10192253006995 1180264556 Salem Sump" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 10192253007008 1180264895 Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm 10192253007015 8888264804 Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm 10192253012408 8888264820 Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm 10192253012415 8888264846 Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm 10192253012422 8888264861 Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm 10192253012439 8888264887 Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm 10192253012446 All Lots

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0211-2026

Related Recalls

Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL

Cardinal Health 200

Class I - Dangerous

The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.

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ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile; CT5504T ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile; CT5505T ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile; DP5001GT ChemoPlus Full Coverage Gown, Open Back, Large, medium Blue, Non- sterile; DP5002GT ChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue, Non-sterile; DP5003GT ChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue, Non-sterile; DP5004GT ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile; CT5500TS ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Sterile; CT5502TS ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503TS ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile; CT5504TS ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Sterile; CT5505TS ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Sterile;

Cardinal Health 200

Class I - Dangerous

Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

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