Recall Z-0209-2026 ยท KNT Tubes, Gastrointestinal (And Accessories)
Cardinal Health 200, LLC
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
| Date | Oct 17, 2025 (initiated Sep 18, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Use error |
| Action | 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 lu |
| Quantity | all lots |
| 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 Au |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851444 | KEITH-A.R.V. Karl M. Block Co., May 10, 1985 |