The Recall Desk

FDA (Devices) recall action 71311

ArthroCare Medical Corporation recalled 2 products on 2015-07-01

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2015-07-01
Critical
0
Units
6,466

Why these products were recalled

Potential component failure resulting in inoperability

Potential component failure causing device inoperability

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.

1–2 of 2

  • ModerateFDA (Devices)··2015-07-01

    ArthroCare Medical Recalls PROcise XP Wand Due to Component Failure

    ArthroCare Medical is recalling 2,355 PROcise XP Wand units because a potential component failure may cause the device to become inoperable during use.

    Product
    PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, ora
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-07-01

    ArthroCare EVAC 70 XTRA Plasma Wand Recall for Component Failure

    ArthroCare Medical Corporation is recalling EVAC 70 XTRA plasma wands due to potential component failure that may cause the device to become inoperable.

    Product
    EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral,
    Category
    Distribution
    0 states