Ballard* Closed Suction Systems
BALLARD* Closed Suction Catheter, Elbow, Neonatal/Pediatric
93manufacturers in China registered for this device type
1catalogue number
40recalls on this code
Who Else Makes It
Concentrated in Zhejiang (29), Guangdong (28), Jiangsu (17). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
Showing 12 of 93. All 93 manufacturers in China registered for Catheters, Suction, Tracheobronchial
Record
| Listed by | Avanos Medical, Inc., United States |
|---|---|
| FDA product code | BSY |
| Device type | Catheters, Suction, Tracheobronchial |
| Device class | Class 1 |
| Regulation | 21 CFR 868.6810 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-06-08 |
| Record revised | 2023-06-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Packaging | Dsp of 10, case of 2 |
| Sizes | Catheter gauge 8 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 93994 | Catheter Gauge 8 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ballard™ | SunMed Group Holdings, LLC | 214 |
| Res-Q-Vac | Repro-Med Systems, Inc. | 201 |
| DAR | Covidien LP | 185 |
| Ballard* Closed Suction System for Adults | Avanos Medical, Inc. | 108 |
| Suction Catheter | Well Lead Medical Co., Ltd. | 97 |
| Avanos | Avanos Medical, Inc. | 63 |
| Ballard* Closed Suction System | Avanos Medical, Inc. | 57 |
| Ballard* Turbo-Cleaning Closed Suction System | Avanos Medical, Inc. | 57 |
| Medline | Medline Industries, Inc. | 49 |
| ProCure | Twin Med, LLC | 47 |
| AirLife™ | Airlife, Inc. | 44 |
| Closed Suction Catheters | Ningbo Xinwell Medical Technology Co., Ltd. | 38 |
Showing 12 of 147. All products under Catheters, Suction, Tracheobronchial
Recalls
10 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 |
|---|---|---|---|---|---|
| 2025-03-19 | Class I | Under Investigation by firm | Lack of sterility assurance for closed suction catheter systems | 1040 units | |
| 2025-03-19 | Class I | Under Investigation by firm | Lack of sterility assurance for closed suction catheter systems | 1980 units | |
| 2025-03-19 | Class I | Under Investigation by firm | Lack of sterility assurance for closed suction catheter systems | 9020 units | |
| 2025-03-19 | Class I | Under Investigation by firm | Lack of sterility assurance for closed suction catheter systems | 2080 units | |
| 2025-03-19 | Class I | Under Investigation by firm | Lack of sterility assurance for closed suction catheter systems | 4000 units | |
| 2025-03-19 | Class I | Under Investigation by firm | Lack of sterility assurance for closed suction catheter systems | 1420 units | |
| 2025-03-19 | Class I | Under Investigation by firm | Lack of sterility assurance for closed suction catheter systems | 0 | |
| 2025-03-19 | Class I | Under Investigation by firm | Lack of sterility assurance for closed suction catheter systems | 9960 units | |
| 2023-10-13 | Class II | Labeling Change Control | Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP. | 4730 cases (94600 devices) | |
| 2023-02-03 | Class I | Component design/selection | Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation. | 220 units | 2024-09-05 |
| 2023-02-03 | Class I | Component design/selection | Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation. | 780 units | 2024-09-05 |
| 2021-11-22 | Class II | Labeling Change Control | Product was distributed with incorrect expiration date. | 2,520 devices (126 cases) | 2023-01-31 |
| 2021-11-22 | Class II | Labeling Change Control | Product was distributed with incorrect expiration date. | 6,280 devices (314 cases) | 2023-01-31 |
| 2021-11-22 | Class II | Labeling Change Control | Product was distributed with incorrect expiration date. | 20 devices (1 case) | 2023-01-31 |
| 2019-11-05 | Class II | Manufacturing material removal | Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially blocked. This may cause the closed suction catheters (CSCs) to inadequately suctio | 114,300 units (37,880 US, 76,420 OUS) | 2023-08-16 |
| 2018-02-07 | Class II | Labeling design | Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. | 32,189 cases (20 units per case – 643,780 units) total | 2022-01-18 |
| 2018-02-07 | Class II | Labeling design | Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. | 32,189 cases (20 units per case – 643,780 units) total | 2022-01-18 |
| 2018-02-07 | Class II | Labeling design | Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. | 32,189 cases (20 units per case – 643,780 units) total | 2022-01-18 |
| 2017-10-06 | Class II | Under Investigation by firm | Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. | 52,660 kits (2,633 cases) with 631,920 saline vials | 2020-09-01 |
| 2017-10-06 | Class II | Under Investigation by firm | Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. | 52,660 kits (2,633 cases) with 631,920 saline vials | 2020-09-01 |
| 2017-10-06 | Class II | Under Investigation by firm | Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. | 52,660 kits (2,633 cases) with 631,920 saline vials | 2020-09-01 |
| 2017-10-06 | Class II | Under Investigation by firm | Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. | 52,660 kits (2,633 cases) with 631,920 saline vials | 2020-09-01 |
| 2017-10-06 | Class II | Under Investigation by firm | Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. | 52,660 kits (2,633 cases) with 631,920 saline vials | 2020-09-01 |
| 2017-10-06 | Class II | Under Investigation by firm | Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. | 52,660 kits (2,633 cases) with 631,920 saline vials | 2020-09-01 |
| 2017-10-06 | Class II | Under Investigation by firm | Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. | 52,660 kits (2,633 cases) with 631,920 saline vials | 2020-09-01 |
| 2017-10-06 | Class II | Under Investigation by firm | Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. | 52,660 kits (2,633 cases) with 631,920 saline vials | 2020-09-01 |
| 2017-10-06 | Class II | Under Investigation by firm | Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. | 52,660 kits (2,633 cases) with 631,920 saline vials | 2020-09-01 |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 | |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 | |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 | |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 | |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 | |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 | |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 | |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 | |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 | |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 | |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 | |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 | |
| 2015-07-29 | Class II | Process control | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. | 2016-01-12 |
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.