FDA recall Z-2078-2021

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2021-05-26

Report date

2021-07-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2078-2021