Home / Recalls / Owen Mumford USA, Inc. / Z-2082-2015

Z-2082-2015 Class II Terminated

Recalled by Owen Mumford USA, Inc. — Marietta, GA

Recall Details

Product Type
Devices
Report Date
July 22, 2015
Initiation Date
December 11, 2014
Termination Date
July 11, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
225 units

Product Description

Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

Reason for Recall

The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.

Distribution Pattern

Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.

Code Information

Lot 7JH, UPC Code 384703800014

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  • Z-0263-2020 Class II — Autoject EI, REF AJ1310 (July 17, 2019)
  • Z-0381-2018 Class II — Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Produc (November 6, 2017)
  • Z-0382-2018 Class II — Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Produc (November 6, 2017)
  • Z-1366-2015 Class II — Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 T (November 24, 2014)