Z-0211-2026Class II

Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch...

Name: Z-0211-2026 Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch...
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: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC... 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-0211-2026
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: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264432 Salem Sump" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 1180264440 Salem Sump" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 1180264457 Salem Sump" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 1180264523 Salem Sump" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264531 Salem Sump" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 1180264549 Salem Sump" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 1180264556 Salem Sump" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 1180264895 Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm 8888264804 Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm 8888264820 Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm 8888264846 Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm 8888264861 Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm 8888264887 Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm SKUs not distributed in US
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: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 10192253006940 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 10192253006957 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 10192253006964 1180264432 Salem Sump" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 10192253006971 1180264440 Salem Sump" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 10192253007053 1180264457 Salem Sump" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 10192253006568 1180264523 Salem Sump" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 10192253007060 1180264531 Salem Sump" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 10192253006988 1180264549 Salem Sump" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 10192253006995 1180264556 Salem Sump" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 10192253007008 1180264895 Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm 10192253007015 8888264804 Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm 10192253012408 8888264820 Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm 10192253012415 8888264846 Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm 10192253012422 8888264861 Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm 10192253012439 8888264887 Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm 10192253012446 All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0211-2026
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

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)