[pending] Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube,
Pending LLM rewrite. Source: FDA_DEVICE Z-0211-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- 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
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 20 Fr/Ch (3.3mm)
- 108 cm 10192253007015 8888264804 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
Distribution
Distributed nationwide across the United States.
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