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U.S. Department of Health and Human Services

Class 1 Device Recall Omnipod DASH Insulin Management System

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  Class 1 Device Recall Omnipod DASH Insulin Management System see related information
Date Initiated by Firm October 17, 2022
Date Posted November 15, 2022
Recall Status1 Open3, Classified
Recall Number Z-0154-2023
Recall Event ID 90987
510(K)Number K211575  
Product Classification Pump, infusion, insulin - Product Code LZG
Product 18239: ASM Omnipod Dash PDM, insulin delivery system.
PT-000010: Assembly, Dash Final PDM U100, mg/dL
PT-000011: Assembly, Dash Final PDM U100, mmol/L
PT-000030: Assembly, DASH PDM, Canada

Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod)


*The part numbers above may be incorporated
into higher level assemblies such as DASH Starter
Kits.
Code Information Part Number/UDI-DI 18239 : 10385082000009 PT 000030: 10385082000122 PT 000010: 10385082000139 PT 000011: 10385082000146 All Serial Numbers and Lots
Recalling Firm/
Manufacturer		 Insulet Corporation
100 Nagog Park
Acton MA 01720-3440
For Additional Information Contact Insulet Customer Care
800-641-2049
Manufacturer Reason
for Recall		 The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM.
FDA Determined
Cause 2		 Device Design
Action On October 17, 2022, the firm notified customers via Urgent Medical Device Correction letters sent via email. The firm followed up with physical mailers. Customers will receive updated Omnipod DASH PDMs in the coming months. Customers do not need to call to receive an updated device, one will automatically be shipped to you when available. Customers were provided with additional precautions to follow until they receive replacement units. If you have any questions regarding the information provided in this Medical Device Correction, please visit our website at www.omnipod.com/insulet-alerts or call 1-800-641-2049 to speak with a dedicated staff member of the Insulet Customer Care team who will be available 24 hours a day, 7 days a week.
Quantity in Commerce 248,288 US; 167,802 OUS
Distribution Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = Insulet Corporation
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