Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0382-2018 — 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.

U.S. FDA — Device Enforcement · United States · 2017-11-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0382-2018
Date of alert: 2017-11-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Owen Mumford USA, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 384701150012

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-0382-2018 — 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.

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