Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE recall — FDA Z-1043-2020
Incomplete seals on the sterile package may compromise the sterility
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Incomplete seals on the sterile package may compromise the sterility
Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a…
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Incomplete seals on the sterile package may compromise the sterility
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a…
Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of…
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a…
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Incomplete seals on the sterile package may compromise the sterility
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness…
The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness…
Product may be contaminated with Listeria monocytogenes.
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