Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0382-2018

November 06, 2017

Class II

Product summary

Firm
Owen Mumford USA, Inc.
Event
Event 78483
Status
Terminated
Classification
Class II
Quantity
708 cartons (21,240 pen needles)
Official record key
device-enforcement:Z-0382-2018

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: 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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packaging. Exposure to liquid may compromise sterility