Z-0664-2020Class II

Radiofrequency Grounding Pad, REF RF-DGP-L

Name: Z-0664-2020 Radiofrequency Grounding Pad, REF RF-DGP-L
Creator: Abbott Medical
Published: 2019-10-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-10-14 / Terminated / root cause: manufacturing process

FDA source

Abbott Medical began a recall of Radiofrequency Grounding Pad, REF RF-DGP-L on 2019-10-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0664-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-14
Posted: 2019-12-10
Terminated: 2021-07-19
Recalling firm: Abbott Medical
Product: Radiofrequency Grounding Pad, REF RF-DGP-L
Product code: GXD Generator, Lesion, Radiofrequency
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 8940 devices
Distribution: nationwide
Product codes and lots: UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0664-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0664-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-10

Product code GXD

K111576Class IINt 2000 Lesioning GeneratorNeuro Therm, Inc. / cleared 2011-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)