Drugs & medicalClass I

Smiths Medical ASD Inc. recalls paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.

Read the official notice →
Date
2024-10-02
Country
United States
Brand
Smiths Medical ASD
Product
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Classification
Class I
Units
Worldwide distribution.
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Smiths Medical ASD recalls

  1. 2024-10-30
  2. US
    Drugs & medicalClass II

    Smiths Medical ASD, Inc. recalls medex Arterial Kit 1/EA, Product Code REF MX7827

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable…

    FDA · DeviceSmiths Medical ASD, Inc.Worldwide distribution.Official notice →
  3. US
    Drugs & medicalClass II

    Smiths Medical ASD Inc. recalls smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

    Uncertainty in the seal integrity of the sterile packaging.

    FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    Smiths Medical ASD Inc. recalls CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP

    Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

    FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution.Official notice →
  5. 2024-09-18
  6. US
    Drugs & medicalClass I

    Smiths Medical ASD Inc. recalls smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number…

    There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.

    FDA · DeviceSmiths Medical ASD Inc.WorldwideOfficial notice →
  7. US
    Drugs & medicalClass I

    Smiths Medical ASD Inc. recalls Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX

    There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.

    FDA · DeviceSmiths Medical ASD Inc.WorldwideOfficial notice →
  8. 2024-09-04
  9. US
    Drugs & medicalClass I

    Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List…

    Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

    FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution.Official notice →
All 39 Smiths Medical ASD recalls →

Other drugs & medical recalls in the United States

  1. 2024-10-02
  2. US
    Drugs & medicalClass I

    Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management…

    The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.

    FDA · DeviceFresenius Kabi USA, LLCUS Nationwide.Official notice →
  3. US
    Drugs & medicalClass I

    Datascope Corp. recalls CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.

    Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and…

    FDA · DeviceDatascope Corp.International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA…Official notice →
  4. US
    Drugs & medicalClass I

    Datascope Corp. recalls CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.

    Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and…

    FDA · DeviceDatascope Corp.International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA…Official notice →
  5. US
    Drugs & medicalClass II

    Wipro GE Healthcare Private Ltd. recalls GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4)…

    GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the…

    FDA · DeviceWipro GE Healthcare Private Ltd.US and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand,…Official notice →
  6. US
  7. US
    Drugs & medicalClass II

    EnviroServe Chemicals Inc. recalls EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson…

    CGMP deviations

    FDA · DrugEnviroServe Chemicals Inc.Product was sent to one distributor in North Carolina.Official notice →
See all drugs & medical recalls →