Color Cuff
Nonsterile Disposable Tourniquet Cuff, Single Bladder, Single Port and Quick Connect Connector
21manufacturers in China registered for this device type
87catalogue 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 GmbH, Switzerland |
|---|---|
| FDA product code | KCY |
| Device type | Tourniquet, Pneumatic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5910 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2021-12-31 (version 4) |
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 |
| Storage | Storage environment temperature -20 to 50 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature -20 to 50 °C; Handling environment humidity 10 to 90 % RH |
| Packaging | Pack of 10 |
| Sizes | Length 8 to 44 in; width 1.75 to 5.5 in |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5922034235 | Length 34.0 in | In distribution |
| 5921109135 | Length 9.0 in | In distribution |
| 5921018135 | Width 3.0 in | In distribution |
| 5922044135 | Width 4.5 in | In distribution |
| 5922024145 | Length 24.0 in | In distribution |
| 5921-034-235NS | In distribution | |
| 5922018235 | Width 3.0 in | In distribution |
| 5921024245 | Width 5.5 in | In distribution |
| 5921018245 | Width 5.5 in | In distribution |
| 5922044235 | Width 4.5 in | In distribution |
| 5921212235 | Length 12.0 in | In distribution |
| 5922024235 | Length 24.0 in | In distribution |
| 5921034235 | Length 34.0 in | In distribution |
| 5921209235 | Width 2.75 in | In distribution |
| 5922024135 | Width 4.0 in | In distribution |
| 5921112135 | Length 12.0 in | In distribution |
| 5921024235 | Length 24.0 in | In distribution |
| 5922024245 | Length 24.0 in | In distribution |
| 5921112235 | Width 2.0 in | In distribution |
| 5921218235 | Width 4.0 in | In distribution |
| 5922218135 | Width 4.0 in | In distribution |
| 5921115135 | Length 15.0 in | In distribution |
| 5922018145 | Length 18.0 in | In distribution |
| 5922008135 | Width 2.5 in | In distribution |
| 5921044135 | Length 44.0 in | In distribution |
| 5921024145 | Width 5.5 in | In distribution |
| 5922012135 | Width 3.0 in | In distribution |
| 5921-030-135NS | In distribution | |
| 5922012235 | Width 3.0 in | In distribution |
| 5922030135 | Length 30.0 in | In distribution |
| 5922218235 | Length 18.0 in | In distribution |
| 5921018145 | Width 5.5 in | In distribution |
| 5921018235 | Length 18.0 in | In distribution |
| 5921212135 | Width 3.5 in | In distribution |
| 5922034135 | Width 4.0 in | In distribution |
| 5921115235 | Width 2.5 in | In distribution |
| 5921209135 | Length 9.0 in | In distribution |
| 5921030135 | Width 4.0 in | In distribution |
| 5921044235 | Width 4.0 in | In distribution |
| 5921-030-235NS | In distribution | |
| 5921030235 | Width 4.0 in | In distribution |
| 5921-218-235NS | In distribution | |
| 5921218135 | Length 18.0 in | In distribution |
| 5922018245 | Width 5.5 in | In distribution |
| 5921024135 | Width 4.0 in | In distribution |
| 5922015135 | Length 15.0 in | In distribution |
| 5922018135 | Length 18.0 in | In distribution |
| 5921-218-135NS | In distribution | |
| 5922030235 | Length 30.0 in | In distribution |
| 5922008235 | Width 2.5 in | In distribution |
| 5921034135 | Length 34.0 in | In distribution |
| 5922015235 | Width 3.25 in | In distribution |
| 5921-034-135NS | In distribution | |
| 5921109235 | Width 1.75 in | In distribution |
| 5921030236 | Length 30.0 in | Withdrawn |
| 5921024146 | Length 24.0 in | Withdrawn |
| 5921024136 | Width 4.0 in | Withdrawn |
| 5921212136 | Length 12.0 in | Withdrawn |
| 5921018246 | Width 5.5 in | Withdrawn |
| 5922044136 | Length 44.0 in | Withdrawn |
| 5921018136 | Length 18.0 in | Withdrawn |
| 5921018236 | Width 3.0 in | Withdrawn |
| 5921212236 | Width 3.5 in | Withdrawn |
| 5921218236 | Width 4.0 in | Withdrawn |
| 5922024136 | Width 4.0 in | Withdrawn |
| 5922015136 | Length 15.0 in | Withdrawn |
| 5921209136 | Width 2.75 in | Withdrawn |
| 5922218136 | Width 4.0 in | Withdrawn |
| 5921034236 | Width 4.0 in | Withdrawn |
| 5921112236 | Length 12.0 in | Withdrawn |
| 5921044136 | Length 44.0 in | Withdrawn |
| 5921024236 | Length 24.0 in | Withdrawn |
| 5922018146 | Width 5.5 in | Withdrawn |
| 5921044236 | Length 44.0 in | Withdrawn |
| 5922018136 | Length 18.0 in | Withdrawn |
| 5921018146 | Length 18.0 in | Withdrawn |
| 5921112136 | Length 12.0 in | Withdrawn |
| 5922030136 | Length 30.0 in | Withdrawn |
| 5922034136 | Length 34.0 in | Withdrawn |
| 5921218136 | Length 18.0 in | Withdrawn |
| 5922044236 | Length 44.0 in | Withdrawn |
| 5921115136 | Width 2.5 in | Withdrawn |
| 5921109136 | Width 1.75 in | Withdrawn |
| 5921115236 | Length 15.0 in | Withdrawn |
| 5921030136 | Length 30.0 in | Withdrawn |
| 5921034136 | Length 34.0 in | Withdrawn |
| 5921109236 | Width 1.75 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 128 |
| Tourniquet, Pneumatic | Stryker Sustainability Solutions | 126 |
| Tourniquet, Pneumatic | VBM Medizintechnik Gmbh | 120 |
| Zimmer | Provision | 104 |
| Tourniquet, Pneumatic | Zimmer Orthopaedic Surgical Products | 91 |
| 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
9 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker Instruments | UDI-DI | 2025-07-02 | Class II | Equipment maintenance | Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovas | 233.230 | |
| Stryker Instruments | UDI-DI | 2023-03-01 | Class II | Under Investigation by firm | Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in ex | 1225 units (packs of 10) | |
| Stryker Instruments | UDI-DI | 2023-03-01 | Class II | Under Investigation by firm | Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in ex | 1206 units (packs of 10) | |
| Stryker Instruments | UDI-DI | 2023-03-01 | Class II | Under Investigation by firm | Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in ex | 1979 units (packs of 10) | |
| Stryker Instruments | UDI-DI | 2023-03-01 | Class II | Under Investigation by firm | Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in ex | 1617 units (packs of 10) | |
| Stryker Instruments | UDI-DI | 2023-03-01 | Class II | Under Investigation by firm | Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in ex | 1730 units (packs of 10) | |
| Stryker Instruments | UDI-DI | 2023-03-01 | Class II | Under Investigation by firm | Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in ex | 1707 units (packs of 10) | |
| Stryker GmbH | UDI-DI | 2019-11-06 | Class II | Under Investigation by firm | There is a potential for the cuff to leak air leading to a loss of vascular occlusion. | 16,380 total | 2021-11-19 |
| Stryker GmbH | UDI-DI | 2019-11-06 | Class II | Under Investigation by firm | There is a potential for the cuff to leak air leading to a loss of vascular occlusion. | 16,380 total | 2021-11-19 |
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 |
|---|---|---|---|---|---|
| 2013-12-06 | Class II | Component change control | The Color Cuff Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having received a luer connector instead of a quick connect fitting. An incorrect connector may lead to a | 5 boxes (50 units) | 2014-02-27 |
| 2011-08-25 | Not classified | Mixed-up of materials/components | Three complaints have been reported indicating that the product inside the package did not match the label description. The units had quick connectors instead of luer lock connectors as stated in the label description. | 5920-000-003 (30 bx) and 5920-000-005 (30 bx) | 2011-10-12 |
| 2010-04-13 | Not classified | Component design/selection | This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside o | 2011-05-16 | |
| 2010-04-13 | Not classified | Component design/selection | This recall is related to the Electi-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside of | 2011-05-16 | |
| 2010-04-13 | Not classified | Component design/selection | This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside o | 2011-05-16 |
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.