[pending] Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stoma
Pending LLM rewrite. Source: FDA_DEVICE Z-0208-2026.
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: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124 Salem
- 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)
- Radiopaque Line
- 10 Fr/Ch (3.3 mm)
- 12 Fr/Ch (4.0 mm)
- 14 Fr/Ch (4.7 mm)
- 16 Fr/Ch (5.3 mm)
- 18 Fr/Ch (6.0 mm)
- Anti-Reflux Valve and Radiopaque Line
- 18 Fr/Ch (6.0 mm) x 48 (122 cm) 10884521000858 All Lots
Distribution
Distributed nationwide across the United States.
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