Cardinal Health 200, LLC recalled Salem Sump gastroduodenal tubes worldwide after reports of anti-reflux valve breakage. The ARV can fail under excessive force during use. Healthcare providers and patients should stop using the device immediately and follow the manufacturer instructions for recall communication.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cardinal Health 200, LLC or your healthcare provider for instructions. Notification method: Letter
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Salem Sump gastroduodenal tubes are used for feeding and decompression in clinical settings. They come in PVC and polyurethane variants with multiple French sizes and lengths.
Excessive force can cause ARV breakage, potentially compromising tube function and safety for patients.
This recall is not described as part of a broader industry pattern in the provided data.
Immediate disposal or replacement is necessary to avoid potential device failure during patient care.
Recall notice and FDA enforcement page linked in the notice.
Replacement or refund timelines are not specified; contact the manufacturer for progression details.
Keep recall notification, model numbers, serial numbers, and correspondence with supplier; photograph ARV if needed.
Product codes/names include multiple Salem Sump PVC and polyurethane gastroduodenal tubes, sizes 10 Fr to 20 Fr. Some variants list different lengths, including 90 cm, 114 cm, and 108 cm. UDI-DI references are listed for several models. Distribution is worldwide, including all US states and numerous international markets.
No injuries or incidents have been reported in the provided data.
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