ASO EU® Wound Closure
Catalogue number 40-2893, listed by Aspen Surgical Products, Inc., United States, under Strip, Adhesive, Closure, Skin. 14 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (5), Guangdong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Qidong Farjoy Medical Material Co., Ltd. | Qidong | Jiangsu | Contract manufacturer | 8 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
| Rfx+care Manufacturing Co., Ltd. | Shaoxing | Zhejiang | Repacker / relabeller | 21 |
| Jiangsu Qiantai Medical Instrument Co., Ltd. | Tai Zhou | Jiangsu | Contract manufacturer | 16 |
| HongYu BioTech (ShenZhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 15 |
| Yafho BIO-Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 14 |
| Zhejiang Hangbiao Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 9 |
| Nantong MedTech Medical Products Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Strip, Adhesive, Closure, Skin
Record
| Listed by | Aspen Surgical Products, Inc., United States |
|---|---|
| FDA product code | FPX |
| Device type | Strip, Adhesive, Closure, Skin |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5240 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2018-12-13 |
| Record revised | 2022-01-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 4, pack of 50 |
| Distribution end date | 2022-01-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40-2893 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterion® Skin Closure | Aspen Surgical Products, Inc. | 53 |
| Aspen® Skin Closure | Aspen Surgical Products, Inc. | 8 |
| Suture Strip® | Derma Sciences Canada, Inc. | 7 |
| ACE | Ace Surgical Supply Co., Inc. | 7 |
| Curad | Medline Industries, Inc. | 6 |
| Henry Schein | Henry Schein, Inc. | 6 |
| Dukal | Dukal LLC | 6 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Shur-Strip® | Derma Sciences Canada, Inc. | 4 |
| CareOne | Ahold U.S.A., Inc. | 1 |
| Walgreens | Walgreen Co. | 1 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 1 |
Showing 12 of 18. All products under Strip, Adhesive, Closure, Skin
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 |
|---|---|---|---|---|---|
| 2013-07-18 | Class II | Process design | Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment includi | 3286 boxes ( 6,353,000) | 2014-04-17 |
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.