Recall Z-2082-2015— Owen Mumford USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Owen Mumford USA, Inc., initiated 2014-12-11, terminated 2017-07-11. It names one FDA 510(k) clearance: K983974. Product: 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: 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..
- Recalling firm
- Owen Mumford USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-11
- Terminated
- 2017-07-11
- Firm location
- Marietta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.