Recall Z-0381-2018— Owen Mumford USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Owen Mumford USA, Inc., initiated 2017-11-06, terminated 2021-02-12. It names one FDA 510(k) clearance: K152339. 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.. 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..
- Recalling firm
- Owen Mumford USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-06
- Terminated
- 2021-02-12
- Firm location
- Marietta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.