The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0382-2018·Announced 2018-01-24

Owen Mumford Recalls Unifine Pentips Pen Needles Due to Sterility Concerns

Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Consumers should check for discoloration on the protective seal.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where sterility may be compromised, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Owen Mumford USA, Inc. is recalling 708 cartons (21,240 units) of Unifine Pentips 5mm x 31G pen needles. These sterile, single-use needles are intended for the subcutaneous injection of drugs from pen injectors. The recall is due to a potential compromise in the end-user packaging that may have allowed water exposure, which could compromise the sterility of the devices.

The affected products are identified by UPC #384701150012 and specific batch and lot numbers: Batch No. AN 1150, Lot No. 1705711.T098; Batch No. 1150REC, Lot No. 1705722.T099; and Batch No. AN 1150HEB, Lot No. 1705722.T100. The products were distributed nationwide in the United States, including 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, and WV.

Consumers should inspect the protective seal of the pen needles for any signs of discoloring or yellowing, which may indicate exposure to liquid. If the seal appears compromised, the product should not be used.

The recalled product

Product
Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
Manufacturer
Owen Mumford USA, Inc.
Category
Medical Device — Needles
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • UPC #384701150012: Batch No. AN 1150
  • Lot No.1705711.T098
  • Batch No. 1150REC
  • Lot No. 1705722.T099
  • Batch No. AN 1150HEB
  • Lot No. 1705722.T100.

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Owen Mumford USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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