Silicone stomach tubes recalled after anti-reflux valve breakage complaints
Cardinal Health is recalling all lots of Salem Sump silicone dual lumen stomach tubes after complaints of anti-reflux 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 Silicone Dual Lumen Stomach Tube with radiopaque line in 10 Fr/Ch x 36 in (product code 8888265108), 12 Fr/Ch (8888265116) 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: 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 — 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 (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
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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