FDA (Devices) recall action 84530
The FDA (Devices) publishes a recall like this one as 54 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 54 pages.
Incomplete seals on the sterile package may compromise the sterility
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Centurion Medical Products is recalling 146 units of ENT Snuffer Kits due to incomplete seals that may compromise sterility.
Centurion Medical Products Corporation is recalling specific sterile pathology containers and kits because incomplete seals may compromise sterility. The products were distributed nationwide and in Ghana.
Centurion Medical Products is recalling 188 units of the OR2020 Basin Set because incomplete seals may compromise sterility.
Centurion Medical Products is recalling 957 Neonatal PICC Trays due to incomplete seals that may compromise sterility. The units were distributed nationwide and to Ghana.
Centurion Medical Products Corporation is recalling blood culture collection kits due to incomplete seals that may compromise sterility.
Centurion Medical Products is recalling various sterile dressing change kits and trays because incomplete seals may compromise sterility.
Centurion Medical Products is recalling sterile vaginal speculums because incomplete seals may compromise sterility. The recall covers 1,100 units distributed nationwide and in Ghana.
Centurion Medical Products Corporation is recalling 75 units of Port Draw Kits due to incomplete seals that may compromise sterility.
Centurion Medical Products Corporation is recalling 160 sterile NICU line change kits because incomplete seals may compromise sterility.
Centurion Medical Products is recalling 100 units of the Driveline System Kit because incomplete seals may compromise sterility.
Centurion Medical Products is recalling 448 chest tube trays because incomplete seals may compromise sterility.
Centurion Medical Products Corporation is recalling 1,720 dental kits because incomplete seals on the sterile packaging may compromise sterility.
Centurion Medical Products is recalling specific tracheostomy care kits and trays because incomplete seals may compromise sterility.
Centurion Medical Products Corporation is recalling specific sterile medical packs and trays because incomplete seals may compromise sterility.
Centurion Medical Products is recalling 1,986 circumcision trays because incomplete seals on the sterile packaging may compromise sterility.
Centurion Medical Products Corporation is recalling specific lots of sterile surgery kits because incomplete seals may compromise sterility.
Centurion Medical Products is recalling specific surgical trays because incomplete seals on the sterile packages may compromise sterility.
Centurion Medical Products is recalling 1,820 sterile nasal speculums due to incomplete package seals that may compromise sterility.
Centurion Medical Products Corporation is recalling sterile uterine sounds because incomplete seals may compromise sterility. The products were distributed nationwide and in Ghana.
Centurion Medical Products is recalling 60 Biopsy Trays because incomplete seals on the sterile package may compromise sterility.
Centurion Medical Products is recalling 108 units of Skin Prep Kits due to incomplete seals that may compromise sterility.
Centurion Medical Products Corporation is recalling specific sterile surgical trays because incomplete seals may compromise sterility. The affected products were distributed nationwide and in Ghana.
Centurion Medical Products is recalling specific Incision and Drainage Trays because incomplete seals may compromise sterility.
Centurion Medical Products is recalling specific tracheostomy care kits because incomplete seals on the sterile packaging may compromise sterility.
Centurion Medical Products is recalling specific lots of Pelvic Exam Kits because incomplete seals may compromise sterility.