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mislabeled as sterile
Samples with high fat content will not count platelets accurately.
These fire escape hoods are sold as "Plus 10® Filter Breathing Unit." The hoods are sealed inside foil bags with blue and white labels on them listing the product name and reading, in part, "It's not just ten minutes of air. It's a lifetime." The foil bags are stored inside blue zippered nylon pouches.
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.
The ESL 500N smoke detectors are hard-wired and require professional installation. The recalled alarms have the following model numbers, which are located on the back of the detectors: 521NB, 521NCSXT, 541NB, 541NCSXT, 541NCXTE, 521NBXT, 521NCSRXT, 541NBXT, 541NCSRH, 541NCSXTE, 521NCRXT, 541NCRXT, and 541NCSRXT. Also on the back of the alarms are the letters, "ESL," and the manufacturing date code of "0223" through "0323" (23rd week of 2002 through 23rd week of 2003). Units that may not work properly can be identified by the lack of the flashing red indicator light, though all units with the aforementioned model and dates codes should be replaced.
This program includes the following Life Fitness treadmills: Model 9000HR: Serial numbers CTB100000-CTB101618, Model 8500: Serial numbers MTB100000-MTB100646, T9I: Serial numbers CTI100000-CTI100746
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.