Gastric sump anti-reflux valves recalled after breakage complaints from excessive force
Cardinal Health is recalling all lots of Salem Sump Anti-Reflux Valves after complaints of valve breakage due to excessive force during use, and is providing additional guidance for use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: complaints report valve breakage during use of a gastric tube component, and no injuries are reported.
Plain-English summary
Salem Sump PVC Tubes, covering the Salem Sump Anti-Reflux Valve under product codes 266197 (CE marked) and 8888266197, are being recalled.
The firm has received complaints regarding Anti-Reflux Valve breakage due to excessive force during use, and is providing additional guidance for use. The record notes this is an expansion of an earlier action, RES 95214.
The recall covers all lots, distributed worldwide including nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes the breakage complaints and reports no injuries. Facilities should follow Cardinal Health's updated guidance for use.
The recalled product
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Gastric tube
Distribution
Part of a larger recall action
This product is one of 6 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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