Mallinckrodt, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 161 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Mallinckrodt, Inc. makes
Mallinckrodt, Inc. manufactures the Knightstar 330 ventilator and the Shiley Tracheosoft XLT extended length tracheostomy tube with disposable inner cannula.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Knightstar 330 Ventilator Ref K003075
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 16 recalls initiated by Mallinckrodt, Inc., the earliest on 2006-11-07 and the most recent on 2022-06-23. By recorded status: 1 ongoing and 15 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, packaging, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 23 Jun 2022 Z-1745-2022 Class II Ongoing 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.
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- 23 Jun 2022 Z-1745-2022 Class II Ongoing 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.
2012
- 10 Feb 2012 Z-1118-2012 Not yet classified Terminated 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.
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- 10 Feb 2012 Z-1119-2012 Not yet classified Terminated 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.
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- 10 Feb 2012 Z-1120-2012 Not yet classified Terminated 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.
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- 10 Feb 2012 Z-1121-2012 Not yet classified Terminated 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.
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- 10 Feb 2012 Z-1122-2012 Not yet classified Terminated 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.
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- 10 Feb 2012 Z-1123-2012 Not yet classified Terminated 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.
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- 10 Feb 2012 Z-1118-2012 Not yet classified Terminated 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.
2011
- 20 Dec 2011 Z-0815-2012 Unclassified (pre-2012) Terminated The firm received complaints from their customers stating that they found open seals on two of their sterilized products.
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- 11 Oct 2011 Z-0830-2012 Unclassified (pre-2012) Terminated 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.
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- 20 May 2011 Z-2859-2011 Unclassified (pre-2012) Terminated 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.
- 20 Dec 2011 Z-0815-2012 Unclassified (pre-2012) Terminated The firm received complaints from their customers stating that they found open seals on two of their sterilized products.
Show all 16 recalls
2010
- 14 Jun 2010 Z-1904-2010 Unclassified (pre-2012) Terminated 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.
- 1 Feb 2010 Z-2081-2012 Class II Terminated 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.
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2008
- 14 Apr 2008 Z-1828-2008 Unclassified (pre-2012) Terminated 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.
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- 7 Apr 2008 Z-1694-2008 Unclassified (pre-2012) Terminated 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.
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- 14 Apr 2008 Z-1828-2008 Unclassified (pre-2012) Terminated 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.
2007
- 24 Aug 2007 Z-0056-2008 Unclassified (pre-2012) Terminated 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
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- 24 Aug 2007 Z-0056-2008 Unclassified (pre-2012) Terminated 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
2006
- 7 Nov 2006 Z-0288-2007 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 7 Nov 2006 Z-0288-2007 Unclassified (pre-2012) Terminated 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.
Frequently asked questions
How many devices does Mallinckrodt, Inc. have in the registry?
The registry currently lists 2 devices for Mallinckrodt, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mallinckrodt, Inc.'s devices?
Among its 2 most recently registered devices, Mallinckrodt, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Mallinckrodt, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Mallinckrodt, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mallinckrodt, Inc.?
FDA recall records list 16 recalls initiated by Mallinckrodt, Inc., the most recent initiated on 23 Jun 2022. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Mallinckrodt, Inc. in the registry?
The most recently registered devices listed for Mallinckrodt, Inc. include KNIGHTSTAR 330 VENTILATOR and SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA.