Radiofrequency Grounding Pad, REF RF-DGP-L
FDA Recall Z-0664-2020 · Posted None
Recalling FirmAbbott Medical
Recall StatusTerminated
Product CodeGXD
Date Initiated2019-10-14
Date Terminated2021-07-19
Product Quantity8940 devices
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.
Firm Action
The firm initiated the recall by letter hand delivered by an Abbott field representative. The letter requested that consignee cease use of the affected lot and return the product with the aid of a field representative.
Root Cause
Process control
Distribution Pattern
nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.