FDA-Device2018-01-24Class II
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.
Owen Mumford USA, Inc.
Hazard
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.
Sold states
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
Affected count
2,660 cartons (266,000 pen needles)
Manufactured in
1755 W Oak Commons Ct, N/A, Marietta, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0381-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief