FDA recall Z-0381-2018

Owen Mumford USA, Inc. · Class II · device

Product

Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.

Reason for recall

Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.

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, NX, UT, VA, VT, WA, WV

Key facts

Status
Terminated
Initiation date
2017-11-06
Report date
2018-01-24
Termination date
2021-02-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0381-2018