Prevena Restor™ Arthro•form™
Prevena Restor™ Arthro•form™ Dressing – 33CM X 30CM
8manufacturers in China registered for this device type
4catalogue numbers in this listing
26510(k) clearances naming this product code
17recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (2), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Shanghai ISO Medical Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 8 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Devon Medical Products (Jiangsu) Ltd | Nantong | Jiangsu | Repacker / relabeller | 12 |
| Nantong MedTech Medical Products Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
| Lightstone Medical Products (Ningbo) Co Ltd | Ningbo | Zhejiang | Specification developer | 3 |
Record
| Listed by | KCI USA, Inc., United States |
|---|---|
| FDA product code | OMP |
| Device type | Negative Pressure Wound Therapy Powered Suction Pump |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-03-04 |
| Record revised | 2021-11-23 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | 1-pack, 5 pack of 5, 5-pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PREVENA RESTOR™ ARTHRO•FORM™ | In distribution | |
| PRE5101 | In distribution | |
| PREVENA RESTOR™ ARTHRO•FORM™ | In distribution | |
| PRE5001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 57 |
| Pico | Smith & Nephew, Inc. | 57 |
| Negative Pressure Wound Therapy Powered Suction Pump | Carilex Medical, Inc. | 43 |
| DeRoyal | Deroyal Industries, Inc. | 34 |
| extriCARE | Oakwell Distribution, Inc. | 32 |
| Renasys | Smith & Nephew, Inc. | 27 |
| MicroDoc Npwt System | Pensar Medical | 26 |
| ExtriCARE | Alleva Medical Ltd | 22 |
| Vcare Alpha | I.V.T. Medical Ltd | 19 |
| V.A.C.® Granufoam™ | KCI USA, Inc. | 19 |
| Avance | Mölnlycke Health Care AB | 18 |
| Avance® Solo | Mölnlycke Health Care AB | 17 |
Showing 12 of 284. All products under Negative Pressure Wound Therapy Powered Suction Pump
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241134 | 2024-05-23 |
| K201571 | 2020-07-08 |
| K200390 | 2020-05-18 |
| K190697 | 2019-11-22 |
| K181505 | 2019-03-28 |
| K183543 | 2019-03-20 |
| K181507 | 2019-02-15 |
| K180855 | 2018-06-01 |
| K173426 | 2018-03-09 |
| K173447 | 2018-03-02 |
| K160487 | 2016-12-09 |
| K153199 | 2016-02-29 |
| K150006 | 2015-11-06 |
| K133276 | 2013-11-19 |
| K132741 | 2013-11-15 |
| K123507 | 2013-04-04 |
| K120033 | 2012-05-31 |
| K111280 | 2011-07-21 |
| K100821 | 2010-06-11 |
| K091585 | 2009-12-29 |
| K083357 | 2009-03-04 |
| K063740 | 2007-06-07 |
| K063692 | 2007-06-07 |
| K063590 | 2007-01-25 |
| K063426 | 2006-12-13 |
| K053627 | 2006-02-06 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| KCI USA, Inc. | UDI-DI | 2025-01-17 | Class II | Device Design | Due to increase in complaints related to leak alarms | 135,268 |
Recalls
14 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 |
|---|---|---|---|---|---|
| 2025-01-17 | Class II | Device Design | Due to increase in complaints related to leak alarms | 2,169 | |
| 2024-11-05 | Class II | Use error | Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors. | 83,721 devices | |
| 2020-06-08 | Class II | Under Investigation by firm | The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy. | 5,823 units | 2023-02-07 |
| 2017-04-28 | Class II | Packaging process control | Potential sterile barrier breach | 5,385 cases | 2018-02-01 |
| 2015-11-25 | Class II | Package design/selection | There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters. | 12,728 units | 2016-11-17 |
| 2014-09-18 | Class II | Error in labeling | A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label id | 1090 pouches (109 boxes) | 2015-07-24 |
| 2014-01-30 | Class II | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing | 20,850 units total | 2015-04-06 |
| 2014-01-30 | Class II | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing | 20,850 units total | 2015-04-06 |
| 2014-01-30 | Class II | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing | 20,850 units total | 2015-04-06 |
| 2014-01-30 | Class II | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing | 20,850 units total | 2015-04-06 |
| 2014-01-30 | Class II | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing | 20,850 units total | 2015-04-06 |
| 2014-01-30 | Class II | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing | 20,850 units total | 2015-04-06 |
| 2014-01-30 | Class II | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing | 20,850 units total | 2015-04-06 |
| 2014-01-30 | Class II | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing | 20,850 units total | 2015-04-06 |
| 2009-11-04 | Not classified | Nonconforming Material/Component | Power cords may crack and fail inside plug with potential for fire hazard. | 24,640 | 2011-01-21 |
| 2009-11-04 | Not classified | Nonconforming Material/Component | Power cords may crack and fail inside plug with potential for fire hazard. | 649 | 2011-01-21 |
| 2009-11-04 | Not classified | Nonconforming Material/Component | Power cords may crack and fail inside plug with potential for fire hazard. | 37,437 | 2011-01-21 |
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.