Recall Z-2078-2021— Owen Mumford USA, Inc.
Class II · Ongoing
Class II FDA medical device recall by Owen Mumford USA, Inc., initiated 2021-05-26. It names one FDA 510(k) clearance: K152339. Product: Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.. 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..
- Recalling firm
- Owen Mumford USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-05-26
- 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 Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.