Dual lumen stomach tubes recalled after anti-reflux valve breakage complaints
Cardinal Health is recalling all lots of Salem Sump dual lumen stomach tubes with anti-reflux valve after complaints of valve breakage due to excessive force during use.
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: Scored 3 under the risk-of-harm criterion: complaints report valve breakage during use of a gastric tube, and no injuries are reported.
Plain-English summary
Salem Sump PVC Tubes are being recalled, covering the Salem Sump Stomach Tube, Dual Lumen with Anti-Reflux Valve, in 14 Fr/Ch (product code 266122), 16 Fr/Ch (266130) and other sizes.
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: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) 266148 Salem Sump" Stomach Tube, Dual Lumen with Anti
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Gastric tube
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: 266122 Salem Sump" Stomach Tube
- Dual Lumen with Anti-Reflux Valve
- 14 Fr/Ch (4.7 mm) 10884521065024 266130 Salem Sump" Stomach Tube
- 16 Fr/Ch (5.3 mm) 10884521065031 266148 Salem Sump" Stomach Tube
- 18 Fr/Ch 10884521065055 8888266106 Salem Sump" Dual Lumen Stomach Tube
- Anti-Reflux Valve 10Fr/Ch (3.3 mm)
- 36" 20884521004655 266130CN Salem Sump" Tube 16FR with CONFIRM NOW
- Nonsterile 10884521141292 266148CN Salem Sump" Tube 8 FR with CONFIRM NOW
- Nonsterile 20884521141305 All Lots
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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