Device Recall Oscor introducer Kit

  • Model / Serial
    model 6089 lot numbers: C4-03103 thru C4-03707.  model 6091 lot numbers: C4-03601 thru C4-03691.  model 6092 lot numbers: C4-03110 thru C4-03684.  model 6093 lot numbers: C4-03136 thru C4-03607.  model 6094 lot numbers: C4-03501 thru C4-03610.  model 6663 lot numbers: C4-03055 thru C4-03741.  model 6663 lot numbers: C4-03280 thru C4-03445.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    nationwide and worldwide.
  • Product Description
    Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away sheath with built-in luer-lock; 1 vessel dilator; 1 50-cm guidewire 1 18-G needle; 1 10-cc syringe. Sterile EO. Manufacturer Oscor Inc. 3816 DeSoto Boulevard, Palm Harbor, FL 34683. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Models 6089, 6091, 6092, 6093, 6094, 6663 and 6664.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA