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Recall Observatory FDA recall evidence

Device product

EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

Z-1780-2018

April 06, 2018

Class II

Product summary

Firm
MHC Medical Products LLC
Event
Event 79950
Status
Ongoing
Classification
Class II
Quantity
46600 syringes
Official record key
device-enforcement:Z-1780-2018

Official wording

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

Code information: Lot 45016

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.