Mallinckrodt, Inc.
Cincinnati, OH, US
Mallinckrodt, Inc. appears in FDA device records in Cincinnati, OH. FDA records list 5 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Mallinckrodt, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Leibel-Flarsheim Company LLCenforcement report, recall
- Liebel-Flarsheim Company LLCregistration, 510(k), enforcement report, recall
- MALLINCKRODT HOSPITAL PRODUCTS, INC.registration
510(k) clearance history
FDA records hold 5 510(k) clearances for Mallinckrodt, Inc. between 2000 and 2020. The busiest year on record is 2000, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2012 | 1 |
| 2016 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193010 | Liebel-Flarsheim IBP Transfer Set | PQH | Substantially Equivalent | |
| K152361 | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System | IZQ | Substantially Equivalent | |
| K121838 | LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM | MQB | Substantially Equivalent | |
| K003075 | KNIGHTSTAR 330 VENTILATOR | MNT | Substantially Equivalent - Subject to Tracking Reg. | |
| K003315 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | JOH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1518293 | 1518293 | Liebel-Flarsheim Company LLC | 2111 EAST GALBRAITH RD., Cincinnati, OH 45237 US | 2026 | |
| 3014527933 | 3014074925 | MALLINCKRODT HOSPITAL PRODUCTS INC. | 440 Route 22 East, Bridgewater, NJ 08807 US | 2026 | |
| 3009140376 | 3009140376 | MALLINCKRODT HOSPITAL PRODUCTS, INC. | 675 McDonnell Blvd, Hazelwood, MO 63042 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MRPAnalyzer, Nitric Oxide
- MRQAnalyzer, Nitrogen Dioxide
- MRNApparatus, Nitric Oxide Delivery
- MROApparatus, Nitric Oxide, Backup Delivery
- MNTContinuous, Minimal Ventilatory Support, Facility Use Ventilator
- BXKGas, Calibration (Specified Concentration)
- DXTInjector And Syringe, Angiographic
- IZQInjector, Contrast Medium, Automatic
- PQHIodinated Contrast Media Transfer Tubing Set
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- IWWShield, Vial
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- FOXStand, Infusion
- FMGStopcock, I.V. Set
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
- IYTSystem, Rebreathing, Radionuclide
- LRPTray, Surgical
- JOHTube Tracheostomy And Tube Cuff
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1745-2022 | INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007 | The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery. | Class II | Open, Classified | |
| Z-1992-2021 | HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW) | Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose. | Class II | Terminated | |
| Z-2834-2018 | Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery. | Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings. | Class II | Terminated | |
| Z-2833-2018 | Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery. | Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings. | Class II | Terminated | |
| Z-1753-2013 | Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures. | A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min. | Class II | Terminated | |
| Z-1123-2012 | Coiled 60" Low Pressure Extension Tube 400 PSI Max; packaged in Plastic and Tyvec pouch, with 100 pouches per case; Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Sterile, The purpose of this product is the injection of contrast media by means of power injector system during a diagnostic procedure. | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. | Terminated | ||
| Z-1122-2012 | Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per case. Sterile, The purpose of this product is the injection of contrast media by means of power injector system during a diagnostic procedure. | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. | Terminated | ||
| Z-1121-2012 | Mallinckrodt Optistar Elite 90" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per case. Sterile, The purpose of this product is the injection of contrast media by means of power injector system during a diagnostic procedure. | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. | Terminated | ||
| Z-1120-2012 | Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per case. Sterile, The purpose of this product is the injection of contrast media by means of power injector system during a diagnostic procedure. | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. | Terminated | ||
| Z-1119-2012 | Liebel-Flarsheim Optistar MR 25 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per case. Sterile, The purpose of this product is the injection of contrast media by means of power injector system during a diagnostic procedure. | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. | Terminated | ||
| Z-1118-2012 | Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per case. Sterile, The purpose of this product is the injection of contrast media by means of power injector system during a diagnostic procedure. | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. | Terminated | ||
| Z-0815-2012 | Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnati, OH Made in Mexico. The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve the projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an injection syringe. | The firm received complaints from their customers stating that they found open seals on two of their sterilized products. | Terminated | ||
| Z-0830-2012 | Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico, Liebel-Flarsheim Company, Cincinnati, OH The Liebel Flarsheim Illumena 150mL Syringes with Handi-Fil Straw are designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures. | Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena 150mL Syringe with Handi-Fil Straw, product 900101. | Terminated | ||
| Z-2859-2011 | Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray. The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw is designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals. | Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101. | Terminated | ||
| Z-1904-2010 | Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237. Facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table. | Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator becoming inoperative. | Terminated | ||
| Z-2081-2012 | The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an injection syringe. | A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that ten packages of Handi Fil were not sealed. | Class II | Terminated | |
| Z-1828-2008 | Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging. | The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug. | Terminated | ||
| Z-1694-2008 | The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipment. The J-Bow component is used to connect the powerhead to a suspension system. | Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff. | Terminated | ||
| Z-0056-2008 | Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO. | Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console and the unit's auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection deliv | Terminated | ||
| Z-0288-2007 | OptiVantage DH Power Injection System. | The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinican, contrast would be injected at a higher or lower flow rate than desired. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain