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Possibly contaminated with Listeria monocytogenes
Cystatin C Reagent marketed without a 510 (k)
Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.
There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.
Presence of foreign substance.
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
Undeclared wheat and milk (foreign language labeling)