Recall Z-2083-2020— Nelson Innovaions, Llc

Name: FDA recall Z-2083-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-11

Class II · Ongoing

Class II FDA medical device recall by Nelson Innovaions, Llc, initiated 2020-02-11. FDA's recall record names no specific 510(k) clearance for this event. Product: NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T. Reason: Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging.

Recalling firm: Nelson Innovaions, Llc
Classification: Class II
Status: Ongoing
Initiated: 2020-02-11
Firm location: Strongsville, OH, United States

Product description

NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T

Reason for recall

Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging

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