Apparatus, Exhaust, Surgical
Smoke Evacuator Suction Device Adjustable Length
3manufacturers in China registered for this device type
11catalogue numbers in this listing
9recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Shandong (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
| Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | FYD |
| Device type | Apparatus, Exhaust, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5070 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2021-08-30 (version 3) |
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 | Pack of 10, pack of 20, pack of 4 |
| Sizes | Length 10 ft |
| Distribution end date | 2021-04-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0700025000 | Length 10.0 ft | In distribution |
| 0700028000 | In distribution | |
| 0700021000 | In distribution | |
| 0700034000 | In distribution | |
| 0700022000 | In distribution | |
| 0700020000S1 | In distribution | |
| 0700040001 | Withdrawn | |
| 0700015000 | Withdrawn | |
| 0700040000 | Withdrawn | |
| 0700020001 | Withdrawn | |
| 0700020000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microtek | Microtek Medical LLC | 57 |
| Surgimedics® | Coastal Life Technologies, Inc. | 23 |
| Virosafe | ConMed Corporation | 22 |
| Buffalo Filter | Buffalo Filter Co., Inc. | 22 |
| ACU-Evac | Acuderm, Inc. | 21 |
| Neptune | Stryker GmbH | 14 |
| RapidVac | Covidien LP | 12 |
| Megadyne | Megadyne Medical Products, Inc. | 12 |
| Geiger Smoke Evacuator Filter | Dermatologic LAB AND Supply, Inc. | 12 |
| Apparatus, Exhaust, Surgical | ConMed Corporation | 10 |
| Conmed Buffalo Filter | ConMed Corporation | 10 |
| Steris | I.C. Medical, Inc. | 9 |
Showing 12 of 142. All products under Apparatus, Exhaust, Surgical
Recalls
4 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 |
|---|---|---|---|---|---|
| 2015-07-20 | Class II | Nonconforming Material/Component | The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak between the Rover and Docker couplers during docking or leaking f | 524, 237 of these are non-conforming | 2016-11-07 |
| 2014-03-26 | Class II | Material/Component Contamination | During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated i | 35,310 unexpired units | 2014-12-11 |
| 2012-06-08 | Class I | Labeling False and Misleading | Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operativ | 2657 | 2016-08-23 |
| 2012-06-08 | Class I | Labeling False and Misleading | Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operativ | 10,394 domestic, 276 international | 2016-08-23 |
| 2012-06-08 | Class I | Labeling False and Misleading | Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operativ | 1075 | 2016-08-23 |
| 2012-06-08 | Class I | Labeling False and Misleading | Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operativ | 5925 domestic 2 international | 2016-08-23 |
| 2004-10-12 | Not classified | Other | The grounding pin may break inside of the electrical plug, resulting in a shock hazard. | 365 | 2005-03-28 |
| 2004-10-12 | Not classified | Other | The grounding pin may break inside of the electrical plug, resulting in a shock hazard. | 1317 | 2005-03-28 |
| 2002-12-03 | Not classified | Other | Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R. | 370 | 2003-07-07 |
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.