Recall Z-0382-2018 ยท FMI Needle, Hypodermic, Single Lumen
Owen Mumford USA, Inc.
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.
| Date | Nov 6, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Environmental control |
| Action | Owen Mumford sent an Urgent Medical Device Recall Notification letter dated November 6, 2017 via email. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to check inventory for affected product, contact the Customer Service Department to arrange return of affected product, complete and return the response form and to either provide a customer list for Owen and Mumford to notify their customers or confirmation that they will notify their customers if further distributed. |
| Quantity | 708 cartons (21,240 pen needles) |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152339 | Unifine Pentips/ Unifine Pentips Plus Owen Mumford, Ltd., Jun 24, 2016 |