Omnipod is being scrutinized by the FDA
I AM STILL HAVING ISSUES
FDA Class 1 Device recall on July 13 2015 to January 2017 on many LOT numbers. I did not get a letter from Omnipod about this.
Lot Numbers:, L40806, L40811, L40895, L40976, L41014, L41025, L41067, L41162, L41171, L41197, L41198, L41250
Expanded Recall:, Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907
The firm, Insulet Corporation, sent an “URGENT: Voluntary Device Recall” letter dated 7/13/2015 to each consignee/customer via Email notification (where possible) on 7/13/15 as well as Federal Express. Customers not responding to the email or Federal Express will receive follow up phone calls. The letter described the product, problem and actions to e taken. The customers were instructed to do the following: If you have Pods from any of these lots, set them aside, we will replace them at no charge; arrange for return and replacement by choosing one of the following methods:
- Complete the online form at https://www.myomnipod.com/podinfo (fastest method).
- Return the enclosed reply card by mail or fax to 1-855-407-3729.
- Contact Insulet Customer Care by calling 1-855-407-3729 (any time day or night).
If you do not have any unused Pods form these lots, reply using one of the methods above.
If you have any question, contact Acting VP RA/QA at 978-600-7000.
Insulet Corp. issued on 11/2/15 the URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes problem of that certain lots of the pod’s needle failed to deploy or there is a delay in the deployment of the needle. Customers not responding to the email or Federal Express will receive additional mailing and/or follow up phone calls. Call Customer Care at 1-855-407-3729 if you have any questions regarding this Field Safety Notification
Quantity in Commerce 24829 boxes Expanded: 26,230.9 boxes Distribution Worldwide Distribution: US (Nationwide) and country of: Switzerland. Recall Status1 Terminated 3 on January 26, 2017