Medline Industries, Inc.
Powerglide Dressing Change KIT
12manufacturers in China registered for this device type
1,221catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Hubei (2), Fujian (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Anji Hongde Medical Products Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 47 |
| Bestreat Safety & First AID Solution Co., Ltd. | Wuhan | Hubei | Manufacturer | 35 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Anji Fang Yuan Sanitary Material Co., Ltd. | Anji | Zhejiang | Repacker / relabeller | 13 |
| Shandong Succare Medical Co., Ltd. | Zibo | Shandong | Manufacturer | 12 |
| Ayida (Xiamen) P&C Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 8 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | MCY |
| Device type | Wound Dressing Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5075 |
| Premarket notification | Exempt |
| Record published | 2016-11-07 |
| Record revised | 2023-10-18 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 16, case of 25, case of 40, case of 24, case of 12 |
| Distribution end date | 2021-07-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNDC2098A | In distribution | |
| DYNJ47293D | In distribution | |
| DYNDL1416 | In distribution | |
| DYNDL1697 | In distribution | |
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| EBSI1216 | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 184 |
| Stradis Medical, LLC. | Stradis Healthcare | 116 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 24 |
| Centurion | Centurion Medical Products Corporation | 24 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 15 |
| Wound CareKit | Mirodx, LLC | 12 |
| LSL Healthcare | Lsl Industries, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 11 |
| carePAC | Extremity Care | 11 |
| Medical Action Industries | Medical Action Industries, Inc. | 8 |
| Curaplex | Bound Tree Medical, LLC | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
Showing 12 of 25. All products under Wound Dressing Kit
Recalls Naming This Product
27 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-08-11 | Not classified | Nonconforming Material/Component | The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products | 1100 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-07-20 | Class II | Nonconforming Material/Component | Downstream recall – manufacturer recalled specific lots of BD ChloraPrep Clear – 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lea | 222,653 total |
| Medline Industries, LP – Northfield | UDI-DI | 2026-06-12 | Class II | Nonconforming Material/Component | The kits contain BD ChloraPrep Clear – 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is co | 3650 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-21 | Class II | Nonconforming Material/Component | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing in | 15662 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-04 | Class II | Nonconforming Material/Component | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached pr | 91 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 486946 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 340 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 538201 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-16 | Class II | Under Investigation by firm | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the | 17550 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-27 | Class II | No Marketing Application | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | 113, 843 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 684 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 1056 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-12-24 | Class II | Packaging change control | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. | 7380 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-19 | Class II | Under Investigation by firm | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening. | 5200 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-02-11 | Class II | Under Investigation by firm | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health. | 108 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-09 | Class II | Under Investigation by firm | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. | 36 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-03-14 | Class II | Process control | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. | 7,673 total non-sterile kits |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | 3297 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | 21154 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-01 | Class II | Under Investigation by firm | This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. | 1770 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2023-05-18 | Class II | Device Design | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 11413 units |
| Medline Industries, LP – Northfield | UDI-DI | 2022-12-07 | Class II | Under Investigation by firm | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile. | 981 units |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 6,420 cases (15,009 units) |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 36 cases (116 units) |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 101,102 cases (227,538 units) |
| Medline Industries, LP – Northfield | UDI-DI | 2022-09-09 | Class II | Process control | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that | 1020 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2022-09-09 | Class II | Process control | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that | 1600 kits |
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.