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
Product summary
- 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
open seal
-
Sterility assurance
breach of sterility