Salem Sump
Dual Lumen Stomach Tube Anti-Reflux Valve 10 Fr/Ch (3.3 mm) x 36 in (91 cm)
3manufacturers in China registered for this device type
30catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | FEG |
| Device type | Tube, Double Lumen For Intestinal Decompression And/Or Intubation |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2023-10-23 |
| Record revised | 2026-01-19 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 50, case of 10 |
| Sizes | Catheter gauge 8 to 18 Fr; length 61 to 122 cm; length 36 to 48 in |
| Distribution end date | 2027-03-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8888266122 | In distribution | |
| 7771010 | In distribution | |
| 7771210 | In distribution | |
| 8888264960E | Length 122 cm | In distribution |
| 7771410 | In distribution | |
| 8888264986E | Length 122 cm | In distribution |
| 8888264929E | Length 122 cm | In distribution |
| 8888266148 | In distribution | |
| 8888266114 | Catheter Gauge 12 Fr | In distribution |
| 8888264929E | Catheter Gauge 12 Fr | In distribution |
| 266148 | Catheter Gauge 18 Fr | In distribution |
| 7771810 | In distribution | |
| 8888264911E | Catheter Gauge 10 Fr | In distribution |
| 7771011 | In distribution | |
| 8888268086E | Length 61 cm | In distribution |
| 8888264945E | Length 122 cm | In distribution |
| 266122 | Catheter Gauge 14 Fr | In distribution |
| 266130 | Catheter Gauge 16 Fr | In distribution |
| 7771811 | In distribution | |
| 8888266106 | Length 36 in | In distribution |
| 7771211 | In distribution | |
| 8888266130 | In distribution | |
| 8888264911E | Length 91 cm | In distribution |
| 7771610 | In distribution | |
| 7771411 | In distribution | |
| 7771611 | In distribution | |
| 266130 | Catheter Gauge 16 Fr | Withdrawn |
| 8888266106 | Catheter Gauge 10 Fr | Withdrawn |
| 266148 | Catheter Gauge 18 Fr | Withdrawn |
| 266122 | Catheter Gauge 14 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Salem Sump | Cardinal Health | 18 |
| Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter | C.R. Bard, Inc. | 14 |
| Axiom® Dual-Sump | Axiom Medical, Inc. | 9 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| Axiom® Uni-Sump | Axiom Medical, Inc. | 7 |
| Bard® Nasogastric Sump Tube and PreVent® Filter and Lopez Valve® with ENFit™ | C.R. Bard, Inc. | 6 |
| Bilbao Dotter | Cook Incorporated | 4 |
| Nasogastric Sump Tube with PreVent® Anti-Reflux Filter And Lopez Valve® | C.R. Bard, Inc. | 4 |
| Kangaroo | Cardinal Health | 3 |
| Marcon | Cook Ireland Ltd | 3 |
| Axiom® Sump-n-Sheath® | Axiom Medical, Inc. | 3 |
| Maglinte | Cook Incorporated | 2 |
Showing 12 of 24. All products under Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 2025-09-18 | Class II | Use error | 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. | all lots |
| Cardinal Health 200, LLC | UDI-DI | 2025-09-18 | Class II | Use error | 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. | all lots |
| Cardinal Health 200, LLC | UDI-DI | 2024-07-24 | Class II | Labeling Change Control | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. | 24,761,100 tubes total |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-09-18 | Class II | Use error | 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. | all lots |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.