Care-E-VAC 3
2 catalogue numbers from CARE-E-VAC 3, listed by Ohio Medical LLC, United States, under Pump, Portable, Aspiration (Manual Or Powered). 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (1), elsewhere (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Avita (Wujiang) Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 15 |
| Shenzhen BI-Rich Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Shenzhen Desida Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Zhongshan A&E Machinery Industry Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 25 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Dikaku Industrial Co., Limited | Hong Kong | Hong Kong | Private-label distributor | 9 |
| Medcodes Healthcare (Shenzhen) Limited | Shenzhen | Guangdong | Manufacturer | 9 |
| Shenzhen Root Innovation Technology Co., Ltd. | Shenzhen | Guangdong | Specification developer | 8 |
| Hetaida Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 8 |
| Zhongshan A&J Medical Equipment Co., Ltd. | Guangdong | Guangdong | Manufacturer | 7 |
Showing 12 of 14. All 14 manufacturers in China registered for Pump, Portable, Aspiration (Manual Or Powered)
Record
| Listed by | Ohio Medical LLC, United States |
|---|---|
| FDA product code | BTA |
| Device type | Pump, Portable, Aspiration (Manual Or Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K062610 |
| Record published | 2020-04-30 |
| Record revised | 2020-04-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2020-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CARE-E-VAC 3 | In distribution | |
| CARE-E-VAC 3 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R&D Batteries, Inc. | R & D Batteries, Inc. | 104 |
| Gomco | Allied Medical LLC | 62 |
| Pump, Portable, Aspiration (Manual Or Powered) | Söring GmbH | 23 |
| Silicone tubing | Medela LLC | 10 |
| Grownsy | Oak Tech LLC | 8 |
| Nasal aspirator | Shenzhen Dongjiang Technology Co., Ltd. | 8 |
| Thopaz | Medela LLC | 6 |
| Precision Medical Inc. | Precision Medical Technologies | 6 |
| Basen | Dongguan Yiyingmei Technology Co., Ltd. | 6 |
| V7 | Hersill SL | 6 |
| Care-E-VAC | Hersill SL | 6 |
| Sscor Quickdraw® | Sscor, Inc. | 5 |
Showing 12 of 216. All products under Pump, Portable, Aspiration (Manual Or Powered)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K081185 | 2008-05-02 |
| K062610 | 2006-09-28 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ohio Medical LLC | 510(k) number | 2018-08-14 | Class II | Nonconforming Material/Component | The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power. | 1443 units | 2020-12-15 |
| Ohio Medical LLC | 510(k) number | 2010-11-08 | Not classified | Device Design | The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened. | 4,183 units | 2012-03-16 |
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 | Closed |
|---|---|---|---|---|---|
| 2021-11-16 | Class II | Employee error | Increase in premature device failures | 649 portable suction pumps and replacement pumps | |
| 2010-05-10 | Not classified | Other | Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use. | 218 bags | 2011-08-19 |
| 2010-05-10 | Not classified | Other | Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use. | 375 units | 2011-08-19 |
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.