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U.S. Department of Health and Human Services

Class 2 Device Recall Omnipod DASH(TM) Insulin Management System

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  Class 2 Device Recall Omnipod DASH(TM) Insulin Management System see related information
Date Initiated by Firm December 18, 2018
Create Date November 07, 2019
Recall Status1 Terminated 3 on May 13, 2020
Recall Number Z-0347-2020
Recall Event ID 82003
510(K)Number K180045  
Product Classification Pump, infusion, insulin - Product Code LZG
Product Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Code Information Lot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136
Recalling Firm/
Manufacturer		 Insulet Corporation
600 Technology Park Dr Ste 200
Billerica MA 01821-4150
Manufacturer Reason
for Recall		 There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.
FDA Determined
Cause 2		 Software design
Action Urgent Medical Device Correction letters dated 12/18/18 were sent to customers.
Quantity in Commerce 264
Distribution US Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = Insulet Corporation
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