BEUDAMED
    2 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C Act: a) Split Dressing - 2"x 2", Yellow, component C-033-0022, vendor part number S1072; b) Tubing Extension Sets and IV Sets component C-FG711297CP, vendor pn FG711297CP; component C-FG711093CP, vendor pn FG711093CP; component C-FG711298CP, vendor pn FG711298CP; component C-FG711092CP, vendor pn FG711092CP; c) Cast Padding component C-9046, vendor pn 9046; component C-9044, vendor pn 9044; component C-9043, vendor pn 9043; component C-9062, vendor pn 9062; d) Scalpel Holder component C-DD1628-6, vendor pn DD1628-6; e) Latex Tubing component C-806-12, vendor pn 806-12; component C-808R, vendor pn 808R; component C-606R, vendor pn 606R; component C-122BA10, vendor pn 122BA10; component C-122BA12, vendor pn 122BA12; component C-122BA07, vendor pn 122BA07; component C-102BA12, vendor pn 102BA12; component C-099BA10, vendor pn 099BA10; component C-102BA10, vendor pn 102BA10; component C-103BA10, vendor pn 103BA10; component C-124BA10, vendor pn 124BA10; component C-140BA10, vendor pn 140BA10; f) Clinic Dropper component C-12548, vendor pn 10-871-00; g) Tongue Blade (depressor) component C-11820-010, vendor pn 07-920-00; h) Catheter Clamp component C-043-0497, vendor pn 033403-887; i) Gillette Good News Razor component C-P4417A, vendor pn 4417GN; j) Prepsicle Round Short Blue Swabstick component C-051-0401, vendor pn SBR20035; k) Tubing component C-SFM3-3050, vendor pn SFM3-3050; component C-SFM3-3650, vendor pn SFM3-3650; l) Specimen Container component C-B9021YN, vendor pn B9021YN; component C-C8846-18, vendor pn 15706-806; The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

    FDA Recall
    Terminated ·Cardinal Health·Product code LRO·September 3, 2011

    Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C Act: a) Split Dressing - 2"x 2", Yellow, component C-033-0022, vendor part number S1072; b) Tubing Extension Sets and IV Sets component C-FG711297CP, vendor pn FG711297CP; component C-FG711093CP, vendor pn FG711093CP; component C-FG711298CP, vendor pn FG711298CP; component C-FG711092CP, vendor pn FG711092CP; c) Cast Padding component C-9046, vendor pn 9046; component C-9044, vendor pn 9044; component C-9043, vendor pn 9043; component C-9062, vendor pn 9062; d) Scalpel Holder component C-DD1628-6, vendor pn DD1628-6; e) Latex Tubing component C-806-12, vendor pn 806-12; component C-808R, vendor pn 808R; component C-606R, vendor pn 606R; component C-122BA10, vendor pn 122BA10; component C-122BA12, vendor pn 122BA12; component C-122BA07, vendor pn 122BA07; component C-102BA12, vendor pn 102BA12; component C-099BA10, vendor pn 099BA10; component C-102BA10, vendor pn 102BA10; component C-103BA10, vendor pn 103BA10; component C-124BA10, vendor pn 124BA10; component C-140BA10, vendor pn 140BA10; f) Clinic Dropper component C-12548, vendor pn 10-871-00; g) Tongue Blade (depressor) component C-11820-010, vendor pn 07-920-00; h) Catheter Clamp component C-043-0497, vendor pn 033403-887; i) Gillette Good News Razor component C-P4417A, vendor pn 4417GN; j) Prepsicle Round Short Blue Swabstick component C-051-0401, vendor pn SBR20035; k) Tubing component C-SFM3-3050, vendor pn SFM3-3050; component C-SFM3-3650, vendor pn SFM3-3650; l) Specimen Container component C-B9021YN, vendor pn B9021YN; component C-C8846-18, vendor pn 15706-806; The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

    FDA Recall
    Terminated ·Cardinal Health·Product code LRP·September 3, 2011