Medical device recalls Moderate risk

Stradis Healthcare, LLC. recalls Blepharoplasty Pack - contains Devon Light Glove Used during surgery

Recall date
April 20, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2037-2015
FDA classification
Class II
Brand / firm
Stradis Healthcare, LLC.
Sold / distributed
Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai

Why it was recalled

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Blepharoplasty Pack - contains Devon Light Glove Used during surgery

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