Stenting Malecot
Nephrostomy Catheter System
1manufacturer
2catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | GBW |
| Device type | Catheter, Peritoneal |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-19 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M001224200 | 20 F Diameter | In distribution |
| M001224210 | 24 F Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jackson-Pratt | Cardinal Health 200, LLC | 28 |
| Cook | Cook Incorporated | 22 |
| Tenckhoff | Cook Incorporated | 13 |
| Taut | Teleflex Medical LLC | 13 |
| Core Dynamics | ConMed Corporation | 9 |
| Silicone Sump Drain Tube | Fortune Medical Instrument Corp. | 9 |
| Arrow | Teleflex Medical LLC | 8 |
| Merit Medical® | Merit Medical Systems, Inc. | 5 |
| Grafco | GF Health Products, Inc | 5 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
| Malecot | Boston Scientific Corporation | 3 |
| DeRoyal | Deroyal Industries, Inc. | 2 |
Showing 12 of 15. All products under Catheter, Peritoneal
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 |
|---|---|---|---|---|---|
| 2017-12-12 | Class II | Under Investigation by firm | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | 422 | 2019-10-24 |
| 2009-03-18 | Not classified | Labeling False and Misleading | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and | 586,276 US; 276,013 OUS total for all products | 2012-02-23 |
| 2006-08-10 | Not classified | Other | Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge. | 4 units | 2007-02-07 |
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.