FDA recall Z-0664-2020

Product

Radiofrequency Grounding Pad, REF RF-DGP-L

Reason for recall

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.

Distribution

nationwide

Key facts

Status

Terminated

Initiation date

2019-10-14

Report date

2019-12-18

Termination date

2021-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0664-2020