Z-0206-2026Class II

Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN...

Name: Z-0206-2026 Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN...
Creator: Cardinal Health 200, LLC
Published: 2025-09-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-09-18 / Open, Classified

FDA source

Cardinal Health 200, LLC began a recall of Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN... on 2025-09-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0206-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-18
Posted: 2025-10-17
Recalling firm: Medtronic, Inc.
Product: Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN
Product code: FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation
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 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 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 commerce: 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 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 codes and lots: Product Code/Product Name/UDI-DI: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 10884521779419 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 10884521779426 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 10884521779433 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 10884521779440 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 10884521779457 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 10192253012774 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 10192253012798 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 10192253012811 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 10192253012835 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 10192253012859 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 10884521779464 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN 10884521779471 All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0206-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0206-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-17
Z-0207-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-17
Z-0208-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-17
Z-0209-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-17
Z-0210-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-17
Z-0211-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-17

Product code FEG

K190923Class IISalem Sump Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth / cleared 2019-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)