FDAFDA · Food and drugs·Recall number Z-0382-2018
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.
Published January 24, 2018 · Recall initiated: November 6, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Owen Mumford USA, Inc.
- Distributor
- 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
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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