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Recall Observatory FDA recall evidence

Device product

Hand Pack - contains Devon Light Glove Used during surgery

Z-2028-2015

April 20, 2015

Class II

Product summary

Firm
Stradis Healthcare, LLC.
Event
Event 71130
Status
Completed
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-2028-2015

Official wording

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

Code information: Pack 888-2376, 888-2397, 888-2414, 888-2471

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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