FDAClass IIJuly 21, 2021

Unifine Pentips Plus recall

Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.

Why was Unifine Pentips Plus recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: 20V4001.Z3999, Lot 20V4001.Z4019 and 20V4001.Z411

Product
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
Recalling firm
Owen Mumford USA, Inc.
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.
Recall date
July 21, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls