FDA (Devices) recall action 79329
The FDA (Devices) publishes a recall like this one as 21 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 21 pages.
Convenience Kit containing components to assist practitioner with IV placement and securement.
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
The agency’s own wording, quoted from the enforcement report.
Centurion Medical Products Corporation is recalling IV Start Kits nationwide. The recall addresses a quality issue with the convenience kits used for IV placement.
Centurion Medical Products Corporation is recalling Latex Free IV Start Sets due to a Class II FDA recall. The products were distributed nationally.
Centurion Medical Products Corporation is recalling MINI PLASTICS SET kits because a PVP Prep Pad does not meet required iodine levels for shelf life.
Centurion Medical Products is recalling Incision & Drainage Kits because a PVP Prep Pad failed to meet required iodine levels for shelf life.
Centurion Medical Products Corporation is recalling Blood Draw Kits because the PVP Prep Pad does not meet required iodine levels for shelf life.
Centurion Medical Products is recalling Minor Dressing Change Trays because a PVP Prep Pad component failed to meet required iodine assay levels for shelf life.
Centurion Medical Products is recalling Neonatal IV Access Sets because the PVP Prep Pad does not meet required iodine levels for shelf life.
Centurion Medical Products Corporation is recalling Infant IV Securement Kits due to a Class II FDA recall. The kits are used to assist with IV placement and securement.
Centurion Medical Products is recalling Excision Trays used for IV placement and securement. The recall is classified as Class II by the FDA.
Centurion Medical Products Corporation is recalling St. Christopher's Securement Sets because the PVP Prep Pad does not meet required iodine assay levels for shelf life.
Centurion Medical Products is recalling General Purpose Instrument Trays because a PVP Prep Pad in the kit does not meet required iodine levels for shelf life.
Centurion Medical Products is recalling suture removal kits because the included PVP prep pads do not meet required iodine levels for their 36-month shelf life.
Centurion Medical Products is recalling specific lots of Catheter Securement System Convenience Kits because the PVP Prep Pad does not meet required iodine levels.
Centurion Medical Products Corporation is recalling specific lots of Neonatal IV Start Kits. The recall is a Class II action, indicating a potential risk of temporary or medically reversible health consequences.
Centurion Medical Products Corporation is recalling Tubing Change Kits because a PVP Prep Pad component does not meet required iodine levels for shelf life.
Centurion Medical Products is recalling SorbaView Shield Dressing Change Trays because a PVP Prep Pad does not meet required iodine levels for shelf life.
Centurion Medical Products Corporation is recalling Wound Care Kits due to a Class II medical device recall. The kits are intended to assist practitioners with IV placement and securement.
Centurion Medical Products is recalling Skin Staple Remover Convenience Kits because the included PVP Prep Pad does not meet required iodine levels for its stated shelf life.
Centurion Medical Products Corporation is recalling Pediatric IV & IV Start Kits. The recall is classified as Class II by the FDA.
Centurion Medical Products is recalling Circumcision Trays because a PVP Prep Pad component failed to meet required iodine assay levels for shelf life.
Centurion Medical Products Corporation is recalling Wound Closure Tray - Facial devices due to a Class II FDA recall.