There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Class I - Dangerous
An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.
An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.
Class I - Dangerous
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Class I - Dangerous
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Cardinal Health 200
Class I - Dangerous
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity
Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
Cardinal Health 200
Class I - Dangerous
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
Cardinal Health 200
Class I - Dangerous
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
Olympus Corporation of the Americas
Class I - Dangerous
A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Quest Medical
Class I - Dangerous
Delivery Sets may have tubing that could become detached that could result in patient infection.
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class I - Dangerous
Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.
GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Class I - Dangerous
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
Roche Molecular Systems
Class I - Dangerous
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms