Device Recall Cordis Smart Control

  • Model / Serial
    All lot numbers for the referenced product numbers.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed to 1141 user/medical facilities nationwide.
  • Product Description
    The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS LABELED SIZES . and lot numbers. || Product is packed in a Tyvek pouch and further packed into a shelf carton. || Product Numbers: C06020SB, C06020MB, C06030SB, C06030MB, C06040SB, C06040MB, C06060SB, CO6060MB, C06080SB, C06080MB, C06100SB, C06100MB, C07020SB, C07020MB, C07030SB, C07030MB, C07040SB, C07040MB, C07060SB, C07060MB, C07080SB, C07080MB, C07100SB, CO7100MB, C08020SB, C08020MB, CO8030SB, C08030MB, C08040SB, C08040MB, C08060SB, C08060MB, C08080SB, C08080MB, C08100SB, C08100MB, C09020SB, C09020MB, C09030SB, C09030MB, C09040SB, C09040MB, C09060SB, C09060MB, C09080SB, C09080NB, C10020SB, C10020MB, C10030SB, C10030MB, C10040SB, C10040MB, C10060SB, C10060MB, C10080SB, C10080MB. || Product number related to dimension as follows: || C06020SB 6mm x 20mm x 80cm || C06020MB 6mm x 20mm x 120cm || C06030SB 6mm x 30mm x 80cm || C06030MB 6mm x 30mm x 120cm || C06040SB 6mm x 40mm x 80cm || C06040MB 6mm x 40mm x 120cm || C06060SB 6mm x 60mm x 80cm || C06060MB 6mm x 60mm x 120cm || C06080SB 6mm x 80mm x 80cm || C06080MB 6mm x 80mm x 120cm || C06100SB 6mm x 100mm x 80cm || C06100MB 6mm x 100mm x 120cm || C07020SB 7mm x 20mm x 80cm || C07020MB 7mm x 20mm x 120cm || C07030SB 7mm x 30mm x 80cm || C07030MB 7mm x 30mm x 120cm || C07040SB 7mm x 40mm x 80cm || C07040MB 7mm x 40mm x 120cm || C07060SB 7mm x 60mm x 80cm || C07060MB 7mm x 60mm x 120cm || C07080SB 7mm x 80mm x 80cm || C07080MB 7mm x 80mm x 120cm || C07100SB 7mm x 100mm x 80cm || C07100MB 7mm x 100mm x 120cm || C08020SB 8mm x 20mm x 80cm || C08020MB 8mm x 20mm x 120cm || C08030SB 8mm x 30mm x 80cm || C08030MB 8mm x 30mm x 120cm || C08040SB 8mm x 40mm x 80cm || C08040MB 8mm x 40mm x 120cm || C08060SB 8mm x 60mm x 80cm || C08060MB 8mm x 60mm x 120cm || C08080SB 8mm x 80mm x 80cm || C08080MB 8mm x 80mm x 120cm || C08100SB 8mm x 100mm x 80cm || C08100MB 8mm x 100mm x 120cm || C09020SB 9mm x 20mm x 80cm || C09020MB 9mm x 20mm x 120cm || C09030SB 9mm x 30mm x 80cm || C09030MB 9mm x 30mm x 120cm || C09040SB 9mm x 40mm x 80cm || C09040MB 9mm x 40mm x 120cm || C09060SB 9mm x 60mm x 80cm || C09060MB 9mm x 60mm x 120cm || C09080SB 9mm x 80mm x 80cm || C09080MB 9mm x 80mm x 120cm || C10020SB 10mm x 20mm x 80cm || C10020MB 10mm x 20mm x 120cm || C10030SB 10mm x 30mm x 80cm || C10030MB 10mm x 30mm x 120cm || C10040SB 10mm x 40mm x 80cm || C10040MB 10mm x 40mm x 120cm || C10060SB 10mm x 60mm x 80cm || C10060MB 10mm x 60mm x 120cm || C10080SB 10mm x 80mm x 80cm || C10080MB 10mm x 80mm x 120cm
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cordis Corporation, 14201 NW 60th Ave, Miami Lakes FL 33014
  • Source
    USFDA