Covidien recalls Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR…
Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than…
Read the official notice →- Date
- 2024-08-14
- Country
- United States
- Brand
- Covidien
- Product
- Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR…
- Classification
- Class I
- Units
- US: KY, OH, GA, MN, IN,UT, IL, NJ, NY, PR, LA, MD, MO, TN, MA, ME, CA, SC, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
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IFU update to address device's battery handling information.
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Covidien recalls McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
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Covidien, LLC recalls EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
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Covidien, LP recalls Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection,…
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FDA · DeviceCovidien, LPWorldwide - US Nationwide distribution in the state of NJ and the countries of…Official notice → - 2024-05-08
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Other drugs & medical recalls in the United States
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Olympus Corporation of the Americas recalls Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
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CareFusion 303, Inc. recalls BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
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GE Medical Systems, LLC recalls SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
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