Drug recall
Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic…
FDA recall event 78483 · Class II · Owen Mumford USA, Inc.
Key facts
| Event ID | 78483 |
|---|---|
| Recall numbers | Z-0381-2018, Z-0382-2018 |
| Recalling firm | Owen Mumford USA, Inc. |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | Nov 6, 2017 |
| Report date | Jan 24, 2018 |
| Termination date | Feb 12, 2021 |
| City | Marietta |
| State | GA |
| Country | United States |
| FEI number | 1000219614 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: