Device Recall Unifine Pentips 5mm x 31G pen needles

  • Model / Serial
    UPC #384701150012: Batch No. AN 1150, Lot No.1705711.T098; Batch No. 1150REC, Lot No. 1705722.T099; Batch No. AN 1150HEB, Lot No. 1705722.T100.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. || Product Usage: || Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Owen Mumford USA, Inc., 1755 W Oak Commons Ct, Marietta GA 30062-2280
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    UPC #384703550018: Batch No. AN 3550, Lot No. 1705722.S846; Batch No. AN 3550AC, Lot No. 1705122.S929.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    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.
  • Manufacturer