Tourniquet, Pneumatic
Tourniquet Color Cuff Single Port, Single Bladder (Light Blue), Quick Connect
21manufacturers in China registered for this device type
126catalogue numbers in this listing
7recalls on this code
Who Else Makes It
Concentrated in Zhejiang (8), Guangdong (8), Shanghai (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Yuyao Guangjing Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Zhejiang Longyou Landmedical Technology Co., Ltd. | Longyou | Zhejiang | Contract manufacturer | 7 |
| Tiantai Shengtengyun Medical Supplies Co., Ltd. | Tiantai County | Zhejiang | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
Showing 12 of 21. All 21 manufacturers in China registered for Tourniquet, Pneumatic
Record
| Listed by | Stryker Sustainability Solutions, United States |
|---|---|
| FDA product code | KCY |
| Device type | Tourniquet, Pneumatic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5910 |
| Establishment | Reprocessor, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2024-11-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
| Sizes | Circumference 9 to 44 in |
| Distribution end date | 2021-02-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 12.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 15.0 in | In distribution |
| N/A | Circumference 44.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 9.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 42.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 12.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 44.0 in | In distribution |
| N/A | Circumference 12.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 12.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 15.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 9.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 44.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 12.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 42.0 in | In distribution |
| N/A | Circumference 9.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 15.0 in | In distribution |
| N/A | Circumference 12.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 9.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 15.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 12.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 9.0 in | In distribution |
| N/A | Circumference 42.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 9.0 in | In distribution |
| N/A | Circumference 44.0 in | In distribution |
| N/A | Circumference 9.0 in | In distribution |
| N/A | Circumference 42.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 9.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 9.0 in | In distribution |
| N/A | Circumference 44.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 12.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 42.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | Circumference 9.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 42.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 44.0 in | In distribution |
| N/A | Circumference 30.0 in | In distribution |
| N/A | Circumference 34.0 in | In distribution |
| N/A | Circumference 12.0 in | Withdrawn |
| N/A | Circumference 9.0 in | Withdrawn |
| N/A | Circumference 9.0 in | Withdrawn |
| N/A | Circumference 12.0 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 128 |
| Tourniquet, Pneumatic | VBM Medizintechnik Gmbh | 120 |
| Zimmer | Provision | 104 |
| Tourniquet, Pneumatic | Zimmer Orthopaedic Surgical Products | 91 |
| Color Cuff | Stryker GmbH | 87 |
| Stryker | Provision | 57 |
| Disposable Tourniquet Cuff | Zhejiang Longyou Lande Medical Technology Co., Ltd. | 45 |
| Zimmer Tourniquet | Renu Medical, Inc. | 42 |
| DTS-3000 | Daesung Maref Co., Ltd. | 42 |
| ExpressAire | Provision | 40 |
| Orantech | Orantech Inc. | 35 |
| A.T.S.® Personalized Pressure® | Zimmer Orthopaedic Surgical Products | 31 |
Showing 12 of 94. All products under Tourniquet, Pneumatic
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stryker Sustainability Solutions | UDI-DI | 2026-03-12 | Class II | Nonconforming Material/Component | Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure. | 56,740 cuffs |
| Stryker Sustainability Solutions | UDI-DI | 2024-05-31 | Class II | Employee error | Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder. | 90 units |
Recalls
5 of these are 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 |
|---|---|---|---|---|---|
| 2023-03-01 | Class II | Process control | Increased incidence of disposable tourniquet cuffs “not able to achieve desired pressure” and “not holding pressure” due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable | 127,894 | |
| 2022-01-21 | Class II | Labeling mix-ups | Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs. | 40 units | 2025-02-26 |
| 2019-10-09 | Class II | Employee error | Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force. | 90 | 2021-01-14 |
| 2016-09-19 | Class II | Device Design | Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block req | 1,695,760 | 2017-06-01 |
| 2015-12-17 | Class II | Under Investigation by firm | Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa. | 450 devices | 2016-07-14 |
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.