Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12
Pending LLM rewrite. Source: FDA_DEVICE Z-0207-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
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: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Du
- 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 (9)
- Product Code/Product Name/UDI-DI: 264929 Salem Sump" Stomach Tube
- Dual Lumen
- 12 Fr/Ch (4.0 mm) 10884521067196 264945 Salem Sump" Stomach Tube
- 14 Fr/Ch (4.7 mm) 10884521067202 264960 Salem Sump" Stomach Tube
- 16 Fr/Ch (5.3 mm) 10884521067219 264986 Salem Sump" Stomach Tube
- 10 Fr/Ch (3.3 mm)
- 24" (61 cm) 10192253012972 8888268086 Salem Sump" Dual Lumen Stomach Tube
- 8 Fr/Ch (2.7 mm)
- 24" (61 cm) 10192253012996 All Lots
Distribution
Distributed nationwide across the United States.
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