Radiofrequency Grounding Pad, REF RF-DGP-L
Check against the official notice below — it lists the full affected range.
Abbott Medical is recalling its Radiofrequency Grounding Pad (model REF RF-DGP-L) distributed nationwide. The affected units were manufactured with the protective release liner oriented incorrectly. When users attempt to remove this disposable liner, a clear film may remain on the grounding pad, which could interfere with proper patient skin contact and result in uneven heating during use. The recall affects 8,940 devices from batch numbers 810319004, 810319005, and 810319021.
The source document does not specify a remedy or what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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 Quantity: 8940 devices Lot/code info: UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.