Cardinal Health Recalls Salem Sump Stomach Tubes Due to Valve Breakage
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes because the Anti-Reflux Valve may break due to improper use. Labeling changes were made to address the issue.
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: The recall is classified as FDA Class II, and the hazard involves a medical device component (Anti-Reflux Valve) breaking, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Cardinal Health 200, LLC is recalling specific models of the CardinalHealth Salem Sump Dual Lumen Stomach Tube. The affected products include 12 Fr, 14 Fr, 16 Fr, and 18 Fr sizes, all sterile and 48 inches long. The recall covers 24,761,100 tubes in total.
The recall was initiated after the firm received reports of breakage in the Anti-Reflux Valve (ARV) caused by improper use. In response to these reports, the manufacturer made changes to the product labeling. The agency has classified this as a Class II recall.
Distribution was nationwide, including Puerto Rico and Guam, as well as government and military channels. The products were also distributed to Chile. Consumers and healthcare providers should check their inventory for the specific model numbers and UDI-DI numbers listed in the official recall notice and follow instructions from the manufacturer or regulatory agencies regarding the use or return of these devices.
The recalled product
- Product
- (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile; (c) CardinalHealth Salem Sump Dua
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 24,761,100
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)
- All lot numbers. UDI-DI numbers: (a) 8888264929
- UDI-DI 10192253012477
- (b) 8888264945
- UDI-DI 10192253012491
- (c) 8888264960
- UDI-DI 10192253012514
- and (d) 8888264986
- UDI-DI 10192253012538
Distribution
Part of a larger recall action
This product is one of 2 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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