OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for

FDA device recall Z-2484-2015 · posted 2015-09-04 · Terminated

Recall details

Recalling firm

Insulet Corporation

Reason for recall

OmniPods (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin

Action taken

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: 1. Complete the online form at https://www.myomnipod.com/podinfo (fastest method). 2. Return the enclosed reply card by mail or fax to 1-855-407-3729. 3. 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. EXPANDED RECALL: 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

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LZG

Quantity affected

24829 boxes Expanded: 26,230.9 boxes

Distribution

Worldwide Distribution: US (Nationwide) and country of: Switzerland.

Date initiated

2015-07-13

Date posted

2015-09-04

Date terminated

2017-01-26

Location

Billerica, MA

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