{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215962", "product_res_number": "Z-0206-2026", "event_date_initiated": "2025-09-18", "event_date_posted": "2025-10-17", "recall_status": "Open, Classified", "res_event_number": "97539", "product_code": "FEG", "k_numbers": [ "K190923" ], "product_description": "Salem Sump PVC Tubes:\n\nProduct Code/Product Name:\n\n8888264911E\tENFit\" SALEM SUMP\" PVC TUBE 10FR 36IN\n8888264929E\tENFit\" SALEM SUMP\" PVC TUBE 12FR 48IN\n8888264945E\tENFit\" SALEM SUMP\" PVC TUBE 14FR 48IN\n8888264960E\tENFit\" Salem Sump\" PVC Tube 16Fr 48IN\n8888264986E\tENFit\" SALEM SUMP\" PVC TUBE 18FR 48IN\n8888266106E\tPVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN\n8888266114E\tPVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN\n8888266122E\tPVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN\n8888266130E\tPVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN\n8888266148E\tPVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN\n8888268060E\tENFit\" SALEM SUMP\" PVC TUBE 6FR 24IN\n8888268086E\tENFit\" Salem Sump\" PVC Tube 8Fr 24IN", "code_info": "Product Code/Product Name/UDI-DI:\n\n8888264911E\tENFit\" SALEM SUMP\" PVC TUBE 10FR 36IN\t10884521779419\n8888264929E\tENFit\" SALEM SUMP\" PVC TUBE 12FR 48IN\t10884521779426\n8888264945E\tENFit\" SALEM SUMP\" PVC TUBE 14FR 48IN\t10884521779433\n8888264960E\tENFit\" Salem Sump\" PVC Tube 16Fr 48IN\t10884521779440\n8888264986E\tENFit\" SALEM SUMP\" PVC TUBE 18FR 48IN\t10884521779457\n8888266106E\tPVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN\t10192253012774\n8888266114E\tPVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN\t10192253012798\n8888266122E\tPVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN\t10192253012811\n8888266130E\tPVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN\t10192253012835\n8888266148E\tPVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN\t10192253012859\n8888268060E\tENFit\" SALEM SUMP\" PVC TUBE 6FR 24IN\t10884521779464\n8888268086E\tENFit\" Salem Sump\" PVC Tube 8Fr 24IN\t10884521779471\n\nAll Lots", "firm_fei_number": "3001236905", "recalling_firm": "Cardinal Health 200, LLC", "address_1": "3651 Birchwood Dr", "city": "Waukegan", "state": "IL", "postal_code": "60085-8337", "additional_info_contact": "Customer Service\n800-292-9332", "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.", "root_cause_description": "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.\n\nThe letter provides customers with additional guidance on how to properly use the Anti-Reflux Valve (ARV):\n\nImportant Instructions:\nAfter 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.\nInstructions:\n1. 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.\n2. 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.\n3. To remove, pull valve in the same direction of assembly. Do not pull at an angle to avoid breaking the valve.\nPlease visit https://www.mycardinalmsds.com for updated electronic IFUs.", "product_quantity": "all lots", "distribution_pattern": "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.", "openfda": { "k_number": [ "K935781", "K926073", "K900035", "K971354", "K771048", "K053410", "K960176", "K132314", "K171619", "K880850", "K921104", "K772282", "K040388" ], "registration_number": [ "2020735", "3005580113", "3001845648", "2032112", "3005670221", "3012104670", "3006795797", "3014656668", "9610849", "3014579161", "3002807314", "3004111573", "1423537", "1417592", "1921846", "3005987240", "3010400865", "9611590", "3015997711", "1061124", "3003903031", "2029015", "1018233", "2011171", "9616088", "3009526575", "1043214", "3006082230", "2029275", "9612030" ], "fei_number": [ "2020735", "3005580113", "3003076831", "3001845648", "3005670221", "3012104670", "3006795797", "3014656668", "3014579161", "3002807314", "3004111573", "1417592", "3005987240", "3002806934", "1921846", "3010400865", "3002807391", "3015997711", "1000160458", "3003903031", "1000512168", "3001236905", "1018233", "2011171", "3009526575", "1043214", "1000237915", "3006082230", "1000306431", "3002902735" ], "device_name": "Tube, Double Lumen For Intestinal Decompression And/Or Intubation", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5980", "device_class": "2" } } ] }