Skip to content
Recall Observatory FDA recall evidence

Device product

Radiofrequency Grounding Pad, REF RF-DGP-L

Z-0664-2020

October 14, 2019

Class II

Product summary

Firm
Abbott Medical
Event
Event 84272
Status
Terminated
Classification
Class II
Quantity
8940 devices
Official record key
device-enforcement:Z-0664-2020

Official wording

Reason: Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.

Code information: UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021

Distribution pattern: nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.