Covidien recalls Salem Sump Dual Lumen Stomach Tubes with incorrect packaging that may cause decreased fluid collection and affect patient care, especially in emergencies.
This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in decreased fluid collection, with the potential to affect patient care, particularly in an emergency situation where the correct size is not readily available.
Covidien is recalling Salem Sump Dual Lumen Stomach Tubes that were packaged incorrectly. Using a 10Fr tube when a 16Fr is needed could lead to decreased fluid collection and potentially harm patient care, especially in emergencies.
The tubes were packaged in a pouch labeled for a 16Fr size but are actually a 10Fr tube. This mismatch could cause the tube to collect less fluid than needed, which might be critical in emergency situations where proper fluid management is essential.
Healthcare professionals who use these tubes for medical decompression may be affected. Patients with intestinal obstructions or stomach distention are at risk if the wrong tube size is used.
Check for the product code 8888264911 on the packaging. The Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm) was sold with incorrect packaging in one lot.
Verify the product code on the packaging to confirm it matches 8888264911.
The tubes were packaged incorrectly in a 16Fr pouch but are actually 10Fr tubes, which could lead to decreased fluid collection and affect patient care.
Check the product code on the packaging. If it matches 8888264911, you may need to contact the manufacturer for guidance.
The recall states potential impact on patient care, but no specific injury mechanism is described. This is a low-risk issue.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0597-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0597-2019 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.