Recall Z-0664-2020— Abbott Medical

Name: FDA recall Z-0664-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-14

Class II · Terminated

Class II FDA medical device recall by Abbott Medical, initiated 2019-10-14, terminated 2021-07-19. It names one FDA 510(k) clearance: K111576. Product: Radiofrequency Grounding Pad, REF RF-DGP-L. Reason: 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..

Recalling firm: Abbott Medical
Classification: Class II
Status: Terminated
Initiated: 2019-10-14
Terminated: 2021-07-19
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K111576 — NT 2000 LESIONING GENERATORNeuro Therm, Inc.·cleared 2011-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.