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U.S. Department of Health and Human Services

Class 2 Device Recall Salem

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 Class 2 Device Recall Salemsee related information
Date Initiated by FirmSeptember 18, 2025
Date PostedOctober 17, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0210-2026
Recall Event ID 97539
510(K)NumberK880850 
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
ProductSalem 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-Reflux Valve, 18 Fr/Ch 8888266106 Salem Sump" Dual Lumen Stomach Tube, Anti-Reflux Valve 10Fr/Ch (3.3 mm), 36" 266130CN Salem Sump" Tube 16FR with CONFIRM NOW, Nonsterile 266148CN Salem Sump" Tube 8 FR with CONFIRM NOW, Nonsterile
Code Information 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, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) 10884521065031 266148 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 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
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information ContactCustomer Service
800-292-9332
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Use error
ActionOn September 18, 2025, the firm notified customers via Urgent Medical Device Product Correction Update letters. This is an update to the notice sent in July 2024 for RES 95214. The present recall includes all lots of additional product codes listed. The letter provides customers with additional guidance on how to properly use the Anti-Reflux Valve (ARV): Important Instructions: After placement of the Salem Sump tube, always inject 10ml-20ml of air before seating the Anti Reflux Valve (ARV) into the blue sump vent lumen. Instructions: 1. Seat the BLUE END of the ARV into the blue sump vent lumen of the Salem Sump tube. Insert the ARV gently into the Salem Sump tube to avoid difficult removal. 2. To cap tube, seat the WHITE END of the ARV into the suction lumen. Insert the ARV gently into the Salem Sump tube to avoid difficult removal. 3. To remove, pull valve in the same direction of assembly. Do not pull at an angle to avoid breaking the valve. Please visit https://www.mycardinalmsds.com for updated electronic IFUs.
Quantity in Commerceall lots
DistributionWorldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KNT
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