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.
Z-0381-2018
Product summary
- Event
- Event 78483
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,660 cartons (266,000 pen needles)
- Official record key
device-enforcement:Z-0381-2018
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 #384703550018: Batch No. AN 3550, Lot No. 1705722.S846; Batch No. AN 3550AC, Lot No. 1705122.S929.
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
packaging. Exposure to liquid may compromise sterility