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Recall Observatory FDA recall evidence

Device product

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

Z-0162-2018

October 23, 2017

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 78464
Status
Terminated
Classification
Class II
Quantity
8,000 units
Official record key
device-enforcement:Z-0162-2018

Official wording

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

Code information: Model No. MSG1285, Lot No. 701893369485

Distribution pattern: 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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    open seal
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of sterility