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Recall Observatory FDA recall evidence

Device product

Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.

Z-2078-2021

May 26, 2021

Class II

Product summary

Firm
Owen Mumford USA, Inc.
Event
Event 88013
Status
Ongoing
Classification
Class II
Quantity
2,593 cartons of 100 ea.
Official record key
device-enforcement:Z-2078-2021

Official wording

Reason: Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.

Code information: Lot numbers: 20V4001.Z3999, Lot 20V4001.Z4019 and 20V4001.Z411

Distribution pattern: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.