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Recall Observatory FDA recall evidence

Device product

EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

Z-1779-2018

April 06, 2018

Class II

Product summary

Firm
MHC Medical Products LLC
Event
Event 79950
Status
Ongoing
Classification
Class II
Quantity
3137 retail units (313700 syringes)
Official record key
device-enforcement:Z-1779-2018

Official wording

Reason: The retail shelf cartons may be labeled with an incorrect lot number.

Code information: Lot 45014

Distribution pattern: US Nationwide Distribution in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, ND, NH, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, WV, and Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The retail shelf cartons may be labeled with an incorrect lot number.