Mallinckrodt Inc
Medical device manufacturer in Bedminster, NJ.
2510(k) clearances
0PMA approvals
16recalls
Device types
510(k) clearances
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1745-2022 Class II | INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas…The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the… | 06/23/2022Open, Classified |
| Z-1123-2012 | Coiled 60" Low Pressure Extension Tube 400 PSI Max; packaged in Plastic and Tyvec pouch…The machine used to package the product was missing a tool, which could prevent the packaging from sealing… | 02/10/2012Terminated |
| Z-1122-2012 | Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim…The machine used to package the product was missing a tool, which could prevent the packaging from sealing… | 02/10/2012Terminated |
| Z-1121-2012 | Mallinckrodt Optistar Elite 90" Y-Tubing with Single Check Valve, Liebel-Flarsheim…The machine used to package the product was missing a tool, which could prevent the packaging from sealing… | 02/10/2012Terminated |
| Z-1120-2012 | Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve, Liebel-Flarsheim…The machine used to package the product was missing a tool, which could prevent the packaging from sealing… | 02/10/2012Terminated |
| Z-1119-2012 | Liebel-Flarsheim Optistar MR 25 mL Syringe w/lateral flow needle, Mallinckrodt…The machine used to package the product was missing a tool, which could prevent the packaging from sealing… | 02/10/2012Terminated |
| Z-1118-2012 | Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt…The machine used to package the product was missing a tool, which could prevent the packaging from sealing… | 02/10/2012Terminated |
| Z-0815-2012 | Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt…The firm received complaints from their customers stating that they found open seals on two of their… | 12/20/2011Terminated |
| Z-0830-2012 | Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL…Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product… | 10/11/2011Terminated |
| Z-2859-2011 | Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103)…Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product… | 05/20/2011Terminated |
| Z-1904-2010 | Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n…Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The… | 06/14/2010Terminated |
| Z-2081-2012 Class II | The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10…A report was received from a Japanese distributor regarding a complaint from a hospital customer stating… | 02/01/2010Terminated |
| Z-1828-2008 | Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media…The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around… | 04/14/2008Terminated |
| Z-1694-2008 | The OptiVantage DH Injection System is a contrast delivery system and is designed to…Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This… | 04/07/2008Terminated |
| 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… | 08/24/2007Terminated |
| Z-0288-2007 | OptiVantage DH Power Injection System.The flow rate programmed on the console may be changed without automatically updating the flow rate… | 11/07/2006Terminated |