Medline Industries, Inc.
Neuro Carpal Tunnel-Ulnar Pack
1manufacturer
3,084catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OJG |
| Device type | Neurological Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4525 |
| Premarket notification | Exempt |
| Record published | 2020-01-05 |
| Record revised | 2024-04-11 (version 8) |
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 6, case of 5, case of 8 |
| Distribution end date | 2022-03-05 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJ906806 | In distribution | |
| DYNJ907830 | In distribution | |
| CDS985529F | In distribution | |
| DYNJ27201A | In distribution | |
| DYNJ60980 | In distribution | |
| DYNJ906625A | In distribution | |
| DYNJ54752G | In distribution | |
| DYNJ80756A | In distribution | |
| DYNJ39220D | In distribution | |
| SPEC0400 | In distribution | |
| DYNJ31249K | In distribution | |
| DYNJ39931D | In distribution | |
| DYNJ39008F | In distribution | |
| DYNJ56509J | In distribution | |
| DYNJ35971G | In distribution | |
| DYNJ81090 | In distribution | |
| DYNJ29196 | In distribution | |
| DYNJ20508M | In distribution | |
| DYNJ39836C | In distribution | |
| DYNJ907865 | In distribution | |
| DYNJ53517 | In distribution | |
| DYNJ906131C | In distribution | |
| DYNJVB91138A | In distribution | |
| DYNJ42417A | In distribution | |
| CDS983067R | In distribution | |
| DYNJ35971K | In distribution | |
| DYNJ0408776X | In distribution | |
| DYNJ87849 | In distribution | |
| DYNJ59397J | In distribution | |
| DYNJ904839A | In distribution | |
| DYNJ86069 | In distribution | |
| DYNJ900093F | In distribution | |
| DYNJ41276L | In distribution | |
| DYNJ49951F | In distribution | |
| DYNJ61906B | In distribution | |
| DYNJ62316C | In distribution | |
| DYNDH1185B | In distribution | |
| DYNJ45320I | In distribution | |
| DYNJ901680D | In distribution | |
| DYNJ68532 | In distribution | |
| DYNJ66997A | In distribution | |
| DYNJ55516C | In distribution | |
| DYNJ83544 | In distribution | |
| CDS780109M | In distribution | |
| DYNJ63462 | In distribution | |
| DYNJ66760 | In distribution | |
| DYNJ55763B | In distribution | |
| DYNJ902505F | In distribution | |
| DYNJ41246G | In distribution | |
| DYNJT4947 | In distribution | |
| DYNJ901072G | In distribution | |
| DYNJ58620 | In distribution | |
| DYNJ61082B | In distribution | |
| DYNJ0134541I | In distribution | |
| DYNJT4402 | In distribution | |
| DYNJ85041 | In distribution | |
| CDS780162AD | In distribution | |
| CDS981740F | In distribution | |
| DYNJ64846 | In distribution | |
| DYNJ66576A | In distribution | |
| DYNJ17133J | In distribution | |
| DYNJ37209B | In distribution | |
| DYNJ910259B | In distribution | |
| DYNJ89450 | In distribution | |
| DYNJ49951D | In distribution | |
| DYNJ0428638M | In distribution | |
| DYNJ60031 | In distribution | |
| DYNJ63378 | In distribution | |
| DYNJ902585A | In distribution | |
| CDS983800I | In distribution | |
| DYNJ63068D | In distribution | |
| DYNJ56819C | In distribution | |
| DYNJ58175C | In distribution | |
| DYNJ0780244N | In distribution | |
| DYNJ80243C | In distribution | |
| DYNJ41225A | In distribution | |
| DYNJ0806248I | In distribution | |
| DYNJ44208D | In distribution | |
| CDS983366P | In distribution | |
| DYNJ83134A | In distribution | |
| DYNJ62616A | In distribution | |
| DYNJ49609C | In distribution | |
| DYNJ38317B | In distribution | |
| DYNJ37751A | In distribution | |
| 65131936 | In distribution | |
| DYNJ05350U | In distribution | |
| DYNJ66111A | In distribution | |
| DYNJ83090A | In distribution | |
| DYNJ36035D | In distribution | |
| DYNJ38974I | In distribution | |
| DYNJ63805 | In distribution | |
| DYNJ59945 | In distribution | |
| DYNJ905829G | In distribution | |
| DYNJ900904D | In distribution | |
| DYNJ04671R | In distribution | |
| DYNJ901072C | In distribution | |
| DYNJ45979C | In distribution | |
| DYNJ68333 | In distribution | |
| DYNJ907594 | In distribution | |
| DYNJ904060D | In distribution | |
| DYNJ0428638J | In distribution | |
| DYNJ34405J | In distribution | |
| DYNJ43000D | In distribution | |
| DYNDA2650 | In distribution | |
| CDS840193Y | In distribution | |
| DYNJ40199I | In distribution | |
| DYNJ68773A | In distribution | |
| DYNJ67075C | In distribution | |
| DYNJ911482 | In distribution | |
| DYNJ33044C | In distribution | |
| DYNJ908833B | In distribution | |
| DYNJ0273071R | In distribution | |
| DYNJ58607A | In distribution | |
| DYNJ68898C | In distribution | |
| DYNJ35491K | In distribution | |
| DYNJ48324L | In distribution | |
| DYNJ61215B | In distribution | |
| DYNJ50743A | In distribution | |
| DYNJ85010 | In distribution | |
| DYNJ906792 | In distribution | |
| DYNJ0532910J | In distribution | |
| DYNJ57442C | In distribution | |
| DYNJ32362M | In distribution | |
| DYNJ901816D | In distribution | |
| DYNJ63798D | In distribution | |
| DYNJ0408776W | In distribution | |
| DYNJ64290A | In distribution | |
| DYNJ60501C | In distribution | |
| DYNJ84872C | In distribution | |
| DYNJ53799 | In distribution | |
| DYNJ31581K | In distribution | |
| CDS983981K | In distribution | |
| DYNJ0495625O | In distribution | |
| DYNJ902324 | In distribution | |
| DYNJ59953I | In distribution | |
| PHS41738G | In distribution | |
| DYNJ37326B | In distribution | |
| DYNJ44141B | In distribution | |
| DYNJ0781802N | In distribution | |
| DYNJ44027D | In distribution | |
| DYNJ35971M | In distribution | |
| DYNJ0842793G | In distribution | |
| DYNJ900352D | In distribution | |
| DYNJ904060A | In distribution | |
| CDS984505F | In distribution | |
| DYNJ908821A | In distribution | |
| DYNJ900116F | In distribution | |
| DYNJ906303D | In distribution | |
| DYNJ35971I | In distribution | |
| DYNJ62137 | In distribution | |
| DYNJ63970 | In distribution | |
| DYNJ66790F | In distribution | |
| DYNJ81469 | In distribution | |
| DYNJ0977547C | In distribution | |
| DYNJ61220C | In distribution | |
| DYNJ37741A | In distribution | |
| DYNJ56509G | In distribution | |
| DYNJ63317 | In distribution | |
| CDS982603O | In distribution | |
| DYNJ82633B | In distribution | |
| DYNJ23052F | In distribution | |
| DYNJ61316A | In distribution | |
| DYNJ17480I | In distribution | |
| DYNJ55296A | In distribution | |
| DYNJ46981B | In distribution | |
| DYNJ82103 | In distribution | |
| DYNJ904861 | In distribution | |
| DYNJ67501B | In distribution | |
| DYNJ04747K | In distribution | |
| DYNJ52243D | In distribution | |
| DYNJV0123O | In distribution | |
| DYNJ0781802O | In distribution | |
| DYNJ66735 | In distribution | |
| CDS983800J | In distribution | |
| DYNJ57760A | In distribution | |
| DYNJ42167D | In distribution | |
| DYNJ62429 | In distribution | |
| DYNJ905620 | In distribution | |
| DYNJ39993A | In distribution | |
| 65140283 | In distribution | |
| DYNJ32770Y | In distribution | |
| DYNJ87185 | In distribution | |
| DYNJ910384A | In distribution | |
| DYNJ51427B | In distribution | |
| DYNJ54396D | In distribution | |
| DYNJ66652B | In distribution | |
| DYNJ906625 | In distribution | |
| DYNJ0175892AK | In distribution | |
| DYNJ53901 | In distribution | |
| DYNJ30469J | In distribution | |
| DYNJ88405 | In distribution | |
| DYNJ42369B | In distribution | |
| SAMPC0631 | In distribution | |
| DYNJ22296K | In distribution | |
| DYNJ61584 | In distribution | |
| DYNJ63317B | In distribution | |
| DYNJ66790 | In distribution | |
| PHS853901F | In distribution | |
| DYNJ900093D | In distribution | |
| DYNJ84063A | In distribution | |
| DYNJ59702D | In distribution | |
| DYNJ82062 | In distribution | |
| DYNJ0990425AD | In distribution | |
| DYNJ64769 | In distribution | |
| DYNJ905653C | In distribution | |
| DYNJ54717 | In distribution | |
| DYNJ38974D | In distribution | |
| DYNJ0190156D | In distribution | |
| DYNJ59718 | In distribution | |
| DYNJ0396948C | In distribution | |
| DYNJ69019B | In distribution | |
| DYNJ67075 | In distribution | |
| DYNDH1553 | In distribution | |
| DYNJ60231A | In distribution | |
| DYNJ59564A | In distribution | |
| DYNJ64188 | In distribution | |
| DYNJ44559A | In distribution | |
| DYNJ81866B | In distribution | |
| DYNJ54814A | In distribution | |
| DYNJ41856C | In distribution | |
| DYNJ49098F | In distribution | |
| DYNJ0175892AC | In distribution | |
| DYNJ0459819Q | In distribution | |
| DYNJ64804 | In distribution | |
| DYNJ69516A | In distribution | |
| DYNJ909744 | In distribution | |
| DYNJ51441 | In distribution | |
| DYNJ907436C | In distribution | |
| DYNJ908893A | In distribution | |
| DYNJ46546J | In distribution | |
| DYNJ67360A | In distribution | |
| DYNJ09462N | In distribution | |
| DYNJ904981C | In distribution | |
| DYNJ88672A | In distribution | |
| DYNJ60526D | In distribution | |
| DYNJ905034A | In distribution | |
| DYNJ55366A | In distribution | |
| DYNJ908835A | In distribution | |
| DYNJ64936 | In distribution | |
| DYNJ905427A | In distribution | |
| DYNJ37741D | In distribution | |
| DYNJ87807 | In distribution | |
| DYNJ0429121G | In distribution | |
| DYNJ58346A | In distribution | |
| DYNJ61079 | In distribution | |
| DYNJ21244M | In distribution | |
| DYNJ60069B | In distribution | |
| DYNJ901990A | In distribution | |
| DYNJ908833A | In distribution | |
| DYNJ62257A | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 25,194 |
| Avid TruCustom | Avid Medical, Inc. | 969 |
| ACS | American Contract Systems, Inc. | 938 |
| Halyard | Avid Medical, Inc. | 718 |
| Regard™ | ROi CPS LLC | 208 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 55 |
| Aligned Medical Solutions | Aligned Medical Solutions | 53 |
| V. Mueller | Steris Corporation | 27 |
| Nico BrainPath Approach | Nico Corporation | 25 |
| V. Mueller | Carefusion 2200, Inc. | 13 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 11 |
| Phasor | Phasor Health, LLC | 8 |
Showing 12 of 24. All products under Neurological Tray
Recalls Naming This Product
39 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-07-08 | Class II | Nonconforming Material/Component | Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges. | 3468 kits | |
| Medline Industries, LP – Northfield | UDI-DI | 2026-06-11 | Class II | Process change control | Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. | 574 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 | 342 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 | 2026-03-24 | Class I | Under Investigation by firm | Medline has identified the presence of particulate within the fluid path of the Manifolds. | 107 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. | 263739 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 | 2026-03-19 | 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. | 1552486 kits | |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-27 | Class I | Under Investigation by firm | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | 2154 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-27 | Class II | Component change control | Unapproved design changes to the products outside of the 510(k) clearance. | 270,311 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 | 2026-02-25 | Class II | No Marketing Application | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | 9645 units | |
| 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 | 7494 units | |
| 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 | 117907 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 | 10184 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 | 160980 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. | 236 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2025-11-26 | Class II | Nonconforming Material/Component | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions. | 12 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 | 1315 kits | |
| Medline Industries, LP – Northfield | UDI-DI | 2025-04-22 | Class I | Nonconforming Material/Component | Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate. | 1853 total | |
| 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. | 354 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. | 2161 kits | |
| 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. | 14589 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-21 | Class II | Nonconforming Material/Component | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. | 65310 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-21 | Class II | Nonconforming Material/Component | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. | 205360 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-06 | Class II | Nonconforming Material/Component | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have r | ||
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-06 | Class II | Nonconforming Material/Component | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have r | 12,889 kits | |
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-16 | Class II | Under Investigation by firm | The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. | 360 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. | 12847 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2024-09-04 | Class II | Under Investigation by firm | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. | 51 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 | 134 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. | 2013 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. | 12,588 total sterile kits | |
| 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. | 12,588 total sterile 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. | 14848 units | |
| 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. | 39391 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. | 6,782 cases (15,253 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 | 2021-10-27 | Class II | Incorrect or no expiration date | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | 30 | 2023-04-05 |
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.