Device Recall MAQUET Bioline Connectors

  • Model / Serial
    BEQ-HG 0284 Connector 3/8" x 3/8" Lot 70041098; BEQ-HG 1113 Connector 3/16" x 3/16" Lot 70041096 (note that this code was in the connector mispackaged in the box)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA state of CA.
  • Product Description
    Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units. || The connectors are designed to be used for performing connections between tubes in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. BEQ-HG Connectors are to be used with MAQUET HLM Tubing sets.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Manufacturer Parent Company (2017)
  • Source
    USFDA