RecallDepth

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

Company
Owen Mumford Usa, Inc.
Recall Initiated
May 26, 2021
Recall Number
Z-2078-2021
Quantity
2,593 cartons of 100 ea.
Firm Location
Marietta, GA

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

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.

Lot / Code Info

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

Root Cause

Package design/selection

Action Taken

The firm sent an e-mail on 05/06/2019 to all the distributors. The distributors were directed to quarantine all affected product and contact the company for return. Distributors were also directed to cease distribution and contact their customers (Pharmacies) with recall notification with instructions to contact Owen Mumford with product return, if any on hand..

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