FDA-Device2015-07-15Class II

Suction Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
Hazard

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

Sold states
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
Affected count
One
Manufactured in
805 Marathon Pkwy Ste 100, N/A, Lawrenceville, GA, United States
Products
Suction Pack - contains Devon Light Glove Used during surgery

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2011-2015

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