Drugs & medicalClass I

Percussionaire Corporation recalls High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123

Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user

Read the official notice →
Date
2024-01-24
Country
United States
Brand
Percussionaire
Product
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Classification
Class I
Units
US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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.

More Percussionaire recalls

  1. 2025-10-22
  2. US
    Drugs & medicalClass I

    Percussionaire Corporation recalls Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line…

    IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of…

    FDA · DevicePercussionaire CorporationWorldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada,…Official notice →
  3. 2025-01-29
  4. US
    Drugs & medicalClass I

    Percussionaire Corporation recalls VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk…

    Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.

    FDA · DevicePercussionaire CorporationWorldwide - U.S. Nationwide distribution in the states of AZ, FL, IL, MS, MO,…Official notice →
  5. 2024-11-06
  6. US
    Drugs & medicalClass I

    Percussionaire Corporation recalls Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway…

    As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a…

    FDA · DevicePercussionaire CorporationU.S.: PA, AR, MI, CA, TX, OH, NY, FL, IL, NE, OR, GA, WI, MO, OK, AL, WV, MT,…Official notice →
  7. 2024-10-09
  8. US
    Drugs & medicalClass I

    Percussionaire Corporation recalls Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

    Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

    FDA · DevicePercussionaire CorporationUS: Nationwide OUS: Israel Japan Russia Switzerland Canada TurkeyOfficial notice →
  9. 2024-01-24
  10. US
    Drugs & medicalClass I

    Percussionaire Corporation recalls Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)

    Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.

    FDA · DevicePercussionaire CorporationUS: RI, CA, TXOfficial notice →
  11. 2023-11-15
  12. US
    Drugs & medicalClass II

    Percussionaire Corporation recalls Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.

    Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL…

    FDA · DevicePercussionaire CorporationUS: CA, ND, MS, MDOfficial notice →
All 8 Percussionaire recalls →

Other drugs & medical recalls in the United States

  1. 2024-01-24
  2. US
    Drugs & medicalClass I

    Maquet Cardiovascular, LLC recalls Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit

    Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards…

    FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution: US (nationwide) and OUS (Foreign) to countries of:…Official notice →
  3. US
    Drugs & medicalClass I

    Percussionaire Corporation recalls Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)

    Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.

    FDA · DevicePercussionaire CorporationUS: RI, CA, TXOfficial notice →
  4. US
    Drugs & medicalClass I

    Globus Medical, Inc. recalls ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

    A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.

    FDA · DeviceGlobus Medical, Inc.Domestic distribution to the following states: CA, CO, MT, SC, WA.…Official notice →
  5. US
    Drugs & medicalClass I

    ROi CPS LLC recalls regard Operative LAP, Item Number 800943001; surgical convenience kit

    Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

    FDA · DeviceROi CPS LLCUS distribution to LouisianaOfficial notice →
  6. US
    Drugs & medicalClass II

    The Procter & Gamble Company recalls Secret OUTLAST Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Protecting Powder, Topical spray can 3.8 oz (107 g),…

    CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene

    FDA · DrugThe Procter & Gamble CompanyNationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands,…Official notice →
  7. US
    Drugs & medicalClass I

    The Procter & Gamble Company recalls Secret, powder fresh, Aluminum chlorohydrate 24%, Anti-Perspirant/Deodorant, Topical spray can Net Wt., (a) 4OZ (113g), NDC…

    Chemical contamination: presence of benzene

    FDA · DrugThe Procter & Gamble CompanyNationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands,…Official notice →
See all drugs & medical recalls →