Radiofrequency Grounding Pad, REF RF-DGP-L
Reported: December 18, 2019 Initiated: October 14, 2019 #Z-0664-2020
Product Description
Radiofrequency Grounding Pad, REF RF-DGP-L
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.
Details
- Recalling Firm
- Abbott Medical
- Units Affected
- 8940 devices
- Distribution
- nationwide
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
Radiofrequency Grounding Pad, REF RF-DGP-L. Recalled by Abbott Medical. Units affected: 8940 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0664-2020.
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