Recall Z-0664-2020
Abbott Medical · initiated October 14, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Radiofrequency Grounding Pad, REF RF-DGP-L
Codes / lots: UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021
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.
FDA-determined cause: Process control
Action taken
The firm initiated the recall by letter hand delivered by an Abbott field representative. The letter requested that consignee cease use of the affected lot and return the product with the aid of a field representative.
Details
- Recall number
- Z-0664-2020
- Initiated
- October 14, 2019
- Terminated
- July 19, 2021
- Product code
- GXD – Generator, Lesion, Radiofrequency
- Quantity
- 8940 devices
- Distribution
- nationwide
- Recalling firm
- Abbott Medical, Plymouth, MN