Medline Industries, Inc.
KIT Adult Cardiac Cabg Dr.grif
1manufacturer
17,468catalogue 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 | OEZ |
| Device type | Cardiovascular Procedure Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Premarket notification | Exempt |
| Record published | 2019-01-27 |
| Record revised | 2024-06-28 (version 10) |
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, case of 6, case of 8 |
| Distribution end date | 2021-07-21 |
| UDI direct marking | Exempt |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 40,731 |
| Avid TruCustom | Avid Medical, Inc. | 2,785 |
| Namic | Medline Industries, Inc. | 2,718 |
| Merit Medical® | Merit Medical Systems, Inc. | 2,399 |
| Halyard | Avid Medical, Inc. | 2,108 |
| ACS | American Contract Systems, Inc. | 1,540 |
| Medline | Medline Industries, Inc. | 428 |
| Stradis Healthcare | Stradis Healthcare | 263 |
| Regard™ | ROi CPS LLC | 192 |
| Stradis | Stradis Healthcare | 108 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 72 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 51 |
Showing 12 of 52. All products under Cardiovascular Procedure Kit
Recalls Naming This Product
76 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 | 489 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 | 2026-07-10 | Class II | Process change control | Kits contain a potentially contaminated component which were recalled by the manufacturer | 263 kits |
| 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 | 4636 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. | 155 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-28 | Class II | Process change control | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen d | 9,272 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-28 | Class II | Process change control | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen d | 9,272 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-28 | Class II | Under Investigation by firm | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in i | 75 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 | 333 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-06 | Class I | Nonconforming Material/Component | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA i | 6775 units |
| 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 | 168968 units |
| 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 | 217390 units |
| 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 | 123030 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 | 2026-03-24 | Class I | Under Investigation by firm | Medline has identified the presence of particulate within the fluid path of the Manifolds. | 567675 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. | 4016 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. | 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. | 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. | 1752096 kits |
| 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. | 19189 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-16 | Class II | Under Investigation by firm | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragmen | 14,379 kits total |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-16 | Class II | Under Investigation by firm | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragmen | 14,379 kits total |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-30 | Class II | Error in labeling | The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older. | 2894 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-08 | Class II | Process control | Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the | 516 |
| 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 | 39315 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 | 154427 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 | 51061 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 | 207196 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. | 450 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2025-12-16 | Class II | Under Investigation by firm | Medline kits containing Stryker’s Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design chang | 96 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-12-16 | Class II | Under Investigation by firm | Medline kits containing Stryker’s Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design chang | 4536 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. | 1,928 total |
| 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. | 633 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. | 32 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-10-27 | Class II | Under Investigation by firm | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap tra | 15 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-10-10 | Class I | Nonconforming Material/Component | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120″ expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may resu | 96,406 total 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 | 5133 kits |
Showing 40 of 76.
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.