Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
FDA Recall Z-0381-2018 · Posted None
Recalling FirmOwen Mumford USA, Inc.
Recall StatusTerminated
Product CodeFMI
Date Initiated2017-11-06
Date Terminated2021-02-12
Product Quantity2,660 cartons (266,000 pen needles)
Reason for Recall
Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
Firm Action
Owen Mumford sent an Urgent Medical Device Recall Notification letter dated November 6, 2017 via email. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to check inventory for affected product, contact the Customer Service Department to arrange return of affected product, complete and return the response form and to either provide a customer list for Owen and Mumford to notify their customers or confirmation that they will notify their customers if further distributed.
Root Cause
Environmental control
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, NX, UT, VA, VT, WA, WV
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.