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Class I

MedTech Current publications and recall entries tagged Class I.

Device RecallsRecall Brief

FDA Classifies Medline Convenience Kit Recall as Class I

FDA has classified the recall of certain Medline convenience kits containing B. Braun bupivacaine hydrochloride components as Class I. Medline Industries, LP is correcting affected kits because they include Huons Bupivacaine Hydrochloride in Dextrose Injection, USP that was recalled for quality issues.

Device RecallsRecall Brief

FDA Classifies BD Intraosseous Needle Set Recall as Class I

FDA has classified the recall of specified BD Intraosseous Vascular Access System Needle Set lots as Class I after out-of-tolerance dimensions were linked to difficulty removing the obturator and potential delays in therapy; the FDA recall database lists Bard Access Systems, Inc. as the recalling firm.