SunMed LLC
AirFlow Adult Resuscitator with B/V Filter, Bag Reservoir, Mask, Attached PEEP Valve and 14' Tubing
8manufacturers in China registered for this device type
1catalogue number
40recalls on this code
Who Else Makes It
Concentrated in Fujian (4), Zhejiang (1), Guangdong (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Xiamen Compower Medical Tech. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
Record
| Listed by | SunMed Group Holdings, LLC, United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2023-10-24 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AF5040MB-PWT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 405 |
| CPR-2 Bag | Mercury Medical Enterprises, LLC | 231 |
| CPR Bag | Mercury Medical Enterprises, LLC | 187 |
| Vital Signs™ | Airlife, Inc. | 102 |
| Medline | Medline Industries, Inc. | 78 |
| Spur® II Pediatric ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 74 |
| Spur® II Adult ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 66 |
| Hudson RCI | Teleflex Medical LLC | 56 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53 |
| Portex | ICU Medical, Inc | 45 |
| Spur® II Infant ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 45 |
| Curaplex® | Bound Tree Medical, LLC | 38 |
Showing 12 of 342. All products under Ventilator, Emergency, Manual (Resuscitator)
Recalls
14 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 | Closed |
|---|---|---|---|---|---|
| 2025-05-01 | Class I | Process control | Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which | 11,358 | |
| 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | ||
| 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | ||
| 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | ||
| 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | ||
| 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | ||
| 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | ||
| 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | ||
| 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | ||
| 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | ||
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 350 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 110 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 361 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 80 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 55 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 60 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 40 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 113 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 76 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 1,742 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 60 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 30 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 5 cases | 2020-05-12 |
| 2018-05-24 | Class II | Mixed-up of materials/components | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | 2 cases | 2020-05-12 |
| 2014-05-16 | Class I | Process change control | The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim. | 251,384 | 2015-11-17 |
| 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| 2004-03-26 | Not classified | Other | In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure. | 60 units | 2004-07-07 |
| 2004-03-26 | Not classified | Other | In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure. | 10 units | 2004-07-07 |
| 2004-03-26 | Not classified | Other | In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure. | 3070 units | 2004-07-07 |
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.