Z-2078-2021 Class II Ongoing
FDA device recall Z-2078-2021 was initiated by Owen Mumford USA, Inc. on May 26, 2021 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 2,593 cartons of 100 ea..
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- May 26, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,593 cartons of 100 ea.
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.
Distribution Pattern
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.
Code Information
Lot numbers: 20V4001.Z3999, Lot 20V4001.Z4019 and 20V4001.Z411