FDA Device recall Z-0382-2018
Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles
- FDA Device
- Class II
- terminated
- Published 2018-01-24
On 2018-01-24 the FDA classified a Class II recall of Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles by Owen Mumford Usa, citing 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 prot….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0382-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-06 |
| Published | 2018-01-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Owen Mumford Usa |
| Distribution | US |
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.
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.
Identifiers
| upc | 384701150012 |
|---|---|
| code_info | 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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0382-2018%22
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