The Recall Desk

FDA (Devices) recall action 81755

Stihler Electronic Gmbh recalled 3 products on 2019-01-30

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2019-01-30
Critical
0
Units
1,069

Why these products were recalled

PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2019-01-30

    Stihler PRISMAFLO II Blood Return Warmer Recalled for Burn Risk

    Stihler Electronic Gmbh is recalling PRISMAFLO II blood return warmers because damage to the heating profile may cause low-level skin burns.

    Product
    Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-01-30

    Stihler PRISMAFLO II S Blood Return Warmer Recalled for Burn Risk

    Stihler Electronic Gmbh is recalling PRISMAFLO II S blood return warmers because damage to the heating profile may cause low-level skin burns.

    Product
    Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-01-30

    Stihler PRISMAFLO II S Blood Return Warmer Recalled for Burn Risk

    Stihler Electronic Gmbh is recalling PRISMAFLO II S blood return warmers because damage to the heating profile may cause low-level skin burns.

    Product
    Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
    Category
    Distribution
    1 state