Convatec
Red Rubber Tiemann 14FR Kit
9manufacturers in China registered for this device type
10catalogue numbers in this listing
18recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (3), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Guangdong Ecan Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | KOD |
| Device type | Catheter, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K010420 |
| Record published | 2016-09-16 |
| Record revised | 2024-01-10 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 100 |
| Sizes | Height 0.5 in; length 11 in; width 6.5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN050246 | Length 11 in | In distribution |
| IPN050247 | Length 11 in | In distribution |
| IPN050242 | Length 11 in | In distribution |
| IPN050249 | Length 11 in | In distribution |
| IPN050241 | Height 0.5 in | In distribution |
| IPN050243 | Height 0.5 in | In distribution |
| IPN050240 | Height 0.5 in | In distribution |
| IPN050244 | Height 0.5 in | In distribution |
| IPN050248 | Width 6.5 in | In distribution |
| IPN050245 | Height 0.5 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 432 |
| Dover | Cardinal Health 200, LLC | 163 |
| Dover | Cardinal Health | 152 |
| MTG | HR Pharmaceuticals Inc. | 59 |
| Cook | Cook Incorporated | 43 |
| Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 30 |
| Magic3™ Intermittent Catheter | C.R. Bard, Inc. | 30 |
| Ureteral Catheter | Well Lead Medical Co., Ltd. | 26 |
| Bardex® Urethral Catheter Robinson Model | C.R. Bard, Inc. | 26 |
| Personal Catheter™ Intermittent Catheter | C.R. Bard, Inc. | 24 |
| DeRoyal | Deroyal Industries, Inc. | 23 |
| Bard® Robinson Catheter | C.R. Bard, Inc. | 22 |
Showing 12 of 150. All products under Catheter, Urological
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2022-09-20 | Class II | Nonconforming Material/Component | Product may not be sterile | 7200 catheters | |
| Teleflex Medical LLC | 510(k) number | 2016-11-22 | Class II | Error in labeling | Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life. | 102,843 units | 2017-11-24 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2019-07-01 | Class II | Equipment maintenance | Potential for product not to be sterile. | 3,700 devices | 2021-11-04 |
| 2014-09-04 | Class II | Labeling Change Control | Misbranding: Although the product labeling identifies the catheters as “soft rubber,” the Natural Rubber Latex caution statement was not printed on the product label. | 193,363 ea. + 1,140 units (total 194,503 units) | 2017-02-22 |
| 2014-05-21 | Class II | Mixed-up of materials/components | Product was packaged with a straight catheter rather than the correct coude (curved) catheter. | 1000 eaches | 2015-11-23 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | see line 1. | 2014-04-29 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | see line 1. | 2014-04-29 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | see line 1. | 2014-04-29 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | see line 1. | 2014-04-29 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | see line 1. | 2014-04-29 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | see line 1. | 2014-04-29 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | see line 1. | 2014-04-29 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | see line 1. | 2014-04-29 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | see line 1. | 2014-04-29 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | see line 1. | 2014-04-29 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | 14,378,890 units | 2014-04-29 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | see line 1. | 2014-04-29 |
| 2011-06-30 | Not classified | Other | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. | See line 1. | 2014-04-29 |
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.