FDAClass IIDecember 18, 2019

Radiofrequency Grounding Pad recall

Radiofrequency Grounding Pad, REF RF-DGP-L

Why was Radiofrequency Grounding Pad 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Radiofrequency Grounding Pad, REF RF-DGP-L
Recalling firm
Abbott Medical
Quantity
8940 devices
Distribution
nationwide
Recall date
December 18, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls