| | Class 2 Device Recall Salem |  |
| Date Initiated by Firm | September 18, 2025 |
|---|
| Date Posted | October 17, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0208-2026 |
|---|
| Recall Event ID |
97539 |
| 510(K)Number | K830710 |
|---|
| Product Classification |
Tubes, gastrointestinal (and accessories) - Product Code KNT
|
| Product | Salem Sump PVC Tubes:
Product Code/Product Name:
8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm)
8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm)
8888265124 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48 (122 cm)
8888265132 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48 (122 cm)
8888265140 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48 (122 cm)
8888266213 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36 (91 cm)
8888266221 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48 (122 cm)
8888266247 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48 (122 cm)
8888266262 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm)
8888266288 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 18 Fr/Ch (6.0 mm) x 48 (122 cm) |
|---|
| Code Information |
Product Code/Product Name/UDI-DI:
8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 10884521000766
8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 10884521020078
8888265124 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48 (122 cm) 10884521020085
8888265132 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48 (122 cm) 10884521020092
8888265140 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48 (122 cm) 10884521020108
8888266213 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36 (91 cm) 10192253012781
8888266221 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48 (122 cm) 10884521000803
8888266247 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48 (122 cm) 10884521000827
8888266262 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm) 10884521000841
8888266288 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 18 Fr/Ch (6.0 mm) x 48 (122 cm) 10884521000858
All Lots |
Recalling Firm/
Manufacturer |
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
|
| For Additional Information Contact | Customer Service
800-292-9332 |
|---|
Manufacturer 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 Determined
Cause 2 | 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. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = KNT
|
|---|
|
|
|
