Microtek
Lingeman Cysto/URO Drain BAG - Liebel/GE OEC 2000/PHILLIPS Tables, 1-EACH
39manufacturers in China registered for this device type
994catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (14), Zhejiang (6), Guangdong (6). 21 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Jiangsu Likang Medical Products Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 17 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Wuhan Huaxin Nonwoven Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 13 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Kunshan Jiehong Nonwoven Product Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 12 |
Showing 12 of 39. All 39 manufacturers in China registered for Drape, Surgical, Antimicrobial
Record
| Listed by | Microtek Medical LLC, United States |
|---|---|
| FDA product code | KKX |
| Device type | Drape, Surgical, Antimicrobial |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K882724 |
| Record published | 2017-01-11 |
| Record revised | 2025-02-05 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store under normal warehouse conditions. |
| Packaging | Pack of 2, pack of 20, pack of 10, pack of 5, pack of 25 |
| Distribution end date | 2017-07-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exact Medical Manufacturing, Inc. | Exact Medical Manufacturing, Inc. | 819 |
| Halyard | O&M Halyard, Inc. | 800 |
| Medline | Medline Industries, Inc. | 517 |
| Convertors | Cardinal Health 200, LLC | 392 |
| Medline Industries, Inc. | Medline Industries, Inc. | 274 |
| TIDIShield | Tidi Products, LLC | 187 |
| DeRoyal | Deroyal Industries, Inc. | 118 |
| Cardinal Health | Cardinal Health 200, LLC | 111 |
| Angiosystems Drape | Angiosystems, Inc. | 109 |
| ComPel Surgical Drape | Standard Textile Co., Inc. | 101 |
| Drape, Surgical, Antimicrobial | Welmed, Inc. | 95 |
| Novo Health Services, LLC | Novo Health Services, LLC | 90 |
Showing 12 of 329. All products under Drape, Surgical, Antimicrobial
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060200 | 2006-05-31 |
| K050322 | 2005-05-17 |
Recalls Naming This Product
10 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Microtek Medical LLC | UDI-DI | 2023-06-23 | Class II | Under Investigation by firm | Certain lots of the products have a Naphthalene odor. | 9,293 cases/68,070 units for all products | |
| Microtek Medical LLC | UDI-DI | 2022-04-08 | Class II | Under Investigation by firm | Latex content in product was labeled incorrectly as latex free. | 12 cases (120 drapes) | 2024-06-05 |
| Ecolab, Inc. | 510(k) number | 2016-11-30 | Class III | Incorrect or no expiration date | The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018 | 40 cases (144 eaches per box) | 2019-08-21 |
| Custom Medical Specialties, Inc. | 510(k) number | 2013-07-12 | Class II | Under Investigation by firm | No endotoxin (LAL) testing to proper level. | 2,610 | 2014-04-08 |
| Ecolab, Inc. | 510(k) number | 2013-07-02 | Class II | Process design | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. | 1800 individual units | 2014-05-14 |
| Ecolab, Inc. | 510(k) number | 2013-07-02 | Class II | Process design | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. | 210, 560 individual units | 2014-05-14 |
| Ecolab, Inc. | 510(k) number | 2013-07-02 | Class II | Process design | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. | 12,546 individual units | 2014-05-14 |
| Ecolab, Inc. | 510(k) number | 2013-07-02 | Class II | Process design | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. | 2,102 individual units | 2014-05-14 |
| Ecolab, Inc. | 510(k) number | 2013-07-02 | Class II | Process design | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. | 6,040 individual units | 2014-05-14 |
| Ecolab, Inc. | 510(k) number | 2013-07-02 | Class II | Process design | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. | 6,000 individual units | 2014-05-14 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-08-23 | Not classified | Error in labeling | This product is being recalled due the product is miss-labeled as being sterilized by EO processing; however, the product was processed using Gamma sterilization. | 5 Cases, 12 drapes per case, 60 Drapes total distrubuted | 2010-12-14 |
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.