Recall Z-2078-2021 ยท FMI Needle, Hypodermic, Single Lumen
Owen Mumford USA, Inc.
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
| Date | May 26, 2021 |
| Status | Open, Classified |
| Reason | Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles. |
| Root cause | Package design/selection |
| Action | The firm sent an e-mail on 05/06/2019 to all the distributors. The distributors were directed to quarantine all affected product and contact the company for return. Distributors were also directed to cease distribution and contact their customers (Pharmacies) with recall notification with instructions to contact Owen Mumford with product return, if any on hand.. |
| Quantity | 2,593 cartons of 100 ea. |
| 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, TX, UT, VA, VT, WA, and 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 |