FDAFDA · Food and drugs·Recall number Z-0664-2020
Radiofrequency Grounding Pad, REF RF-DGP-L
Published December 18, 2019 · Recall initiated: October 14, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Medical
- Distributor
- nationwide
- Lot
- UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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