Z-0664-2020 Class II Terminated
FDA device recall Z-0664-2020 was initiated by Abbott Medical on October 14, 2019 and is designated Class II. 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 w… The recall status is terminated (terminated July 19, 2021). Affected quantity: 8940 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- October 14, 2019
- Termination Date
- July 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8940 devices
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.
Distribution Pattern
nationwide
Code Information
UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021