Reported Apr 1, 2020 · Terminated
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D:…
Insulet Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Insulet Corporation · 100 Nagog Park · Acton, MA · 01720-3440
Is this the product you have?
- Omnipod DASH Personal Diabetes Manager (PDM)
- Catalog numbers US18239
- M/DPDM-USA1-D001-MG-USA1
- EUPT-000010 -
- M/DINT1-D001-MG
- PT-000011 M/DINT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump)
- Lot codes and dates
- Software Version 1.0.50 and earlier Lots
83 of 83 codes
L000120L000121L000122L000123L000124L000125L000126L000127L000128L000129L000130L000131L000132L000133L000134L000135L000136L000137L000138L000139L000140L000141L000142L000143L000144L000145L000146L000147L000148L000149L000150L000151L000152L000153L000154L000155L000156L000157L000158L000159L000160L000161L000162L000163L000164L000165L000166L000167L000168L000169L000170L000171L000172L000173L000174L000175L000176L000177L000178L000179
- Software Version 1.0.50 and earlier Lots
- Amount recalled
- 32756 (US), 1420 (International)
Where it was sold
- Nationwide
Why it was recalled
In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may lead to hypoglycemia or hyperglycemia.
This product could cause temporary or reversible health problems — stop using it.
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