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Open, Classified

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

FDA Recall Z-2078-2021 · Posted None

Recalling FirmOwen Mumford USA, Inc.
Recall StatusOpen, Classified
Product CodeFMI
Date Initiated2021-05-26
Product Quantity2,593 cartons of 100 ea.

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.

Firm Action

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..

Root Cause

Package design/selection

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152339Unifine Pentips/ Unifine Pentips PlusOwen Mumford, Ltd. · 2016-06-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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