Maquet Medical Systems USA recalls BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or…
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms:…
Read the official notice →- Date
- 2024-02-14
- Country
- United States
- Brand
- Maquet Medical Systems
- Product
- BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
More Maquet Medical Systems recalls
- 2024-05-22
USMaquet Medical Systems USA recalls CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
FDA · DeviceMaquet Medical Systems USAUS Nationwide distribution in the states of NJ & TX.Official notice →- 2024-02-21
- US
Maquet Medical Systems USA recalls BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
- 2024-02-14
- US
Maquet Medical Systems USA recalls Bubble Sensor (REF: 70105.5720)
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
FDA · DeviceMaquet Medical Systems USAAZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.Official notice → - 2023-12-27
- US
Maquet Medical Systems USA recalls Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be…
FDA · DeviceMaquet Medical Systems USADomestic distribution Nationwide. Foreign distribution to Argentina,…Official notice → - US
Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the…
CARDIOHELP-i System was not properly tested to measure leakage current
FDA · DeviceMaquet Medical Systems USANationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan,…Official notice → - 2023-12-20
- US
Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the…
Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the…
FDA · DeviceMaquet Medical Systems USAWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
Other drugs & medical recalls in the United States
- 2024-02-14
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2)…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Beckman Coulter, Inc. recalls Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Barco N.V. recalls Barco MDSC-8527 NXF, Part Number K9352421
Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MNA decoder is blocked.
- US
G & H Wire Company recalls FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
FDA · DeviceG & H Wire CompanyWorldwide - US Nationwide distribution in the states of UT, MO, WV, TX, NJ and…Official notice → - US
Philips North America recalls Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.
FDA · DevicePhilips North AmericaWorldwide - US Nationwide distribution in the states of FL and NY. The…Official notice → - US
Philips North America recalls BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801;…
Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs,…
FDA · DevicePhilips North AmericaDomestic distribution nationwide. International distribution worldwide.Official notice →