Reported Dec 23, 2015 · Terminated
MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump…
Medtronic MiniMed Inc.
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: Medtronic MiniMed Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219
Is this the product you have?
- MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes.
- Lot codes and dates
1,052 of 1,052 codes
NG1000742HNG1001185HNG1001199HNG1001204HNG1001206HNG1002461HNG1006813HNG1007995HNG1013701HNG1015570HNG1016916HNG1017305HNG1019509HNG1019517HNG1019519HNG1019521HNG1019522HNG1019523HNG1019528HNG1019530HNG1019533HNG1019534HNG1019536HNG1019543HNG1019544HNG1019547HNG1019549HNG1019550HNG1019551HNG1019553HNG1019555HNG1019556HNG1019557HNG1019558HNG1019559HNG1019561HNG1019562HNG1019564HNG1019565HNG1019566HNG1019567HNG1019568HNG1019569HNG1019571HNG1019572HNG1019573HNG1019576HNG1019577HNG1019578HNG1019579HNG1019580HNG1019581HNG1019583HNG1019585HNG1019586HNG1019587HNG1019588HNG1019589HNG1019590HNG1019591H
- Amount recalled
- 1052 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Possible cause is either lack of greasing or deficient greasing in a ball bearing assembly of the motor.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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