Z-0381-2018Class II

Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles

Name: Z-0381-2018 Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles
Creator: Owen Mumford USA, Inc.
Published: 2017-11-06
License: https://open.fda.gov/license/

Owen Mumford USA, Inc. / initiated 2017-11-06 / Terminated / root cause: manufacturing process

FDA source

Owen Mumford USA, Inc. began a recall of 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... on 2017-11-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0381-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-06
Posted: 2018-01-17
Terminated: 2021-02-12
Recalling firm: Owen Mumford USA, Inc.
Product: 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.
Product code: FMI Needle, Hypodermic, Single Lumen
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.
Root cause tag: manufacturing process
FDA root cause: Environmental control
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.
Quantity in commerce: 2,660 cartons (266,000 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, NX, UT, VA, VT, WA, WV
Product codes and lots: UPC #384703550018: Batch No. AN 3550, Lot No. 1705722.S846; Batch No. AN 3550AC, Lot No. 1705122.S929.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0381-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0381-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-17
Z-0382-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-17

Product code FMI

K152339Class IIUnifine Pentips/ Unifine Pentips PlusOwen Mumford, Ltd. / cleared 2016-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)