Medical device recalls Moderate risk

Medline Industries Inc recalls Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glo…

Recall date
October 23, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0162-2018
FDA classification
Class II
Brand / firm
Medline Industries Inc
Sold / distributed
Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Canada.

Why it was recalled

Possible open seal on top portion of the package. Could cause breach of sterility.

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

What was recalled

Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.

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