Medline Industries, Inc.
Caesarean Section Postpartum K
3manufacturers in China registered for this device type
5,487catalogue numbers in this listing
Who Else Makes It
Concentrated in Anhui (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medical Sterilizing Co., Ltd. | Hefei | Anhui | Contract manufacturer | 8 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OHM |
| Device type | Cesarean Section Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Premarket notification | Exempt |
| Record published | 2021-11-08 |
| Record revised | 2024-01-05 (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 2, case of 3, case of 4, case of 5, pack of 3, pack of 2 |
| Distribution end date | 2021-07-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
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| DYNJ65576 | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 7,091 |
| ACS | American Contract Systems, Inc. | 533 |
| Regard™ | ROi CPS LLC | 78 |
| DeRoyal | Deroyal Industries, Inc. | 32 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 32 |
| Medline | Medline Industries, Inc. | 7 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 6 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 6 |
| Aligned Medical Solutions | Aligned Medical Solutions | 3 |
| Henry Schein | Henry Schein, Inc. | 2 |
| Halyard | Avid Medical, Inc. | 2 |
| Invenio | GRI-Alleset, Inc. | 1 |
Recalls Naming This Product
21 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 | 2026-07-20 | 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 | 352 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 | 168 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-04-27 | Class II | Process control | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | 49,654 kits total |
| Medline Industries, LP – Northfield | UDI-DI | 2026-04-27 | Class II | Process control | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | 49,654 kits total |
| 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 | 4525 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 | 12529 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-12-12 | Class II | Nonconforming Material/Component | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive. | 96 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-09-30 | Class II | Under Investigation by firm | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previousl | 11032 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2025-06-12 | Class II | Other | Affected convenience kits contain BD ChloraPrep Clear – 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infectio | 48 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-03 | Class II | Under Investigation by firm | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | 1098 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. | 605 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. | 102561 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. | 58765 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-06-27 | Class II | Process control | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suc | 35 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-03-22 | Class II | Under Investigation by firm | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | 1753 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 | 483 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. | 11,886 cases (27,144 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) |
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.