Reported Dec 18, 2019 · Terminated
Radiofrequency Grounding Pad, REF RF-DGP-L
Abbott Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Medical · 5050 Nathan Ln N · Plymouth, MN · 55442-3209
Is this the product you have?
- Radiofrequency Grounding Pad, REF RF-DGP-L
- Lot codes and dates
- UDI05415067028914
- Batch Numbers
810319004810319005and 810319021
- Amount recalled
- 8940 devices
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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