Abbott Medical recalls Radiofrequency Grounding Pad, REF RF-DGP-L

Recall date

October 14, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0664-2020

FDA classification

Class II

Brand / firm

Abbott Medical

Sold / distributed

nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Radiofrequency Grounding Pad, REF RF-DGP-L