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Salem Sump PVC Tubes recallZ-0207-2026 · Cardinal Health 200, LLC · initiated Sep 18, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Use error

What the company is doing

On 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.

Recall details

Recall number
Z-0207-2026
Status
Open, Classified
Initiated by the company
Sep 18, 2025
Posted by the FDA
Oct 17, 2025
Recalling firm
Cardinal Health 200, LLC
Quantity
all lots
Product code
KNT
FDA submissions
K810156
Distribution
Worldwide - 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.

Product description

Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Dual Lumen, 18 Fr/Ch (6.0 mm) 5558264957 Salem Sump" COILED TUBE 16Fr/Ch (5.3 mm) 5558264965 Salem Sump" TUBE 16 Fr/Ch (5.3 mm) 5558264973 Salem Sump" COILED TUBE 18Fr/Ch (6.0 mm) 5558264981 Salem Sump" TUBE 18 Fr/Ch 18Fr/Ch (6.0 mm) 8888264911 Salem Sump" Dual Lumen Stomach Tube, 10 Fr/Ch (3.3 mm), 36" (91 cm) 8888268060 Salem Sump" Dual Lumen Stomach Tube 6 Fr/Ch (2.0 mm), 24" (61 cm) 8888268086 Salem Sump" Dual Lumen Stomach Tube, 8 Fr/Ch (2.7 mm), 24" (61 cm)

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Product Code/Product Name/UDI-DI: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 10884521067196 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 10884521067202 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 10884521067219 264986 Salem Sump" Stomach Tube, Dual Lumen, 18 Fr/Ch (6.0 mm) 10884521067226 5558264957 Salem Sump" COILED TUBE 16Fr/Ch (5.3 mm) 50192253008171 5558264965 Salem Sump" TUBE 16 Fr/Ch (5.3 mm) 50192253008195 5558264973 Salem Sump" COILED TUBE 18Fr/Ch (6.0 mm) 50192253008201 5558264981 Salem Sump" TUBE 18 Fr/Ch 18Fr/Ch (6.0 mm) 50192253008218 8888264911 Salem Sump" Dual Lumen Stomach Tube, 10 Fr/Ch (3.3 mm), 36" (91 cm) 10192253012453 8888268060 Salem Sump" Dual Lumen Stomach Tube 6 Fr/Ch (2.0 mm), 24" (61 cm) 10192253012972 8888268086 Salem Sump" Dual Lumen Stomach Tube, 8 Fr/Ch (2.7 mm), 24" (61 cm) 10192253012996 All Lots

Devices named in this recall

11 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 97539).

Sources and updates

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