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The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
Non delivery of insulin by pump after electrostatic discharge.
mislabeled as sterile
Samples with high fat content will not count platelets accurately.
Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.
May be contaminated with iron, chromium and nickel from stainless steel equipment failure during manufacture.
The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator.
Performance failure complaints.
Firm shortened calibration frequency to 7 days from 14 days.
Template needle may fracture leaving tip in patient.
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.
Instructions For Use include addtional information on configuration for selecting Power on Lead
Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved.
Water ingresses into the device when in prolonged contact with water causing device to malfunction.
Some devices may have an incorrect inner label which shows Product # 504302L with a length of 50cm, while the outer label is correctly labeled as Product # 504300L with the length of 104mm.
Some devices may have an incorrect inner label which shows Product # 504302L with a length of 50cm, while the outer label is correctly labeled as Product # 504300L with the length of 104cm.