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.

Read the official notice →
Date
2024-09-18
Country
United States
Brand
Smiths Medical ASD
Product
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Classification
Class I
Units
Worldwide
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 Details may be shortened or out of date; the official notice is the authoritative source.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 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 →
  3. 2024-10-02
  4. US
    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.

    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. 2024-09-04
  8. 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 →
  9. 2024-08-14
  10. US
    Drugs & medicalClass I

    Smiths Medical ASD Inc. recalls CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses:…

    The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

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

    Smiths Medical ASD Inc. recalls CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial,…

    CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air…

    FDA · DeviceSmiths Medical ASD Inc.WorldwideOfficial notice →
All 39 Smiths Medical ASD recalls →

Other drugs & medical recalls in the United States

  1. 2024-09-18
  2. US
    Drugs & medicalClass II

    Bard Peripheral Vascular Inc recalls Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen…

    Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur…

    FDA · DeviceBard Peripheral Vascular IncWorldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The…Official notice →
  3. US
    Drugs & medicalClass II

    MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number…

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

    FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    PACIFIC LASERTECH, LLC recalls 25-LHP-928, HeNe Laser System, 25 mW

    These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall…

    FDA · DevicePACIFIC LASERTECH, LLCUS Nationwide DistributionOfficial notice →
  5. US
    Drugs & medicalClass I

    B Braun Medical Inc recalls Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U

    Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream…

    FDA · DeviceB Braun Medical IncUS distribution to AL, CA, GA, IL, MI, and TX.Official notice →
  6. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using…

    Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions…

    FDA · DeviceOlympus Corporation of the AmericasNationwideOfficial notice →
  7. US
    Drugs & medicalClass III

    Elevate Oral Care recalls Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the…

    LABELING: LABEL MIX-UP.

    FDA · DrugElevate Oral Care120 direct customers, Nationwide US. No foreign, DOD/VA.Official notice →
See all drugs & medical recalls →