Reported Nov 9, 2016 · Terminated
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23";…
Unomedical As
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: Unomedical As · Aholmvej 1 3 Osted · Roskilde · N/A
Is this the product you have?
9 of 9 products
| # | Product as published |
|---|---|
| 1 | Silhouette Paradigm 13mm, 18" |
| 2 | Silhouette 43" |
| 3 | Silhouette 23" |
| 4 | Silhouette Paradigm 43" |
| 5 | Silhouette Paradigm 23" |
| 6 | Silhouette Paradigm 13mm, 23" |
| 7 | Silhouette Paradigm 13mm, 43" |
| 8 | Silhouette Paradigm 13mm, 32" |
| 9 | Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin |
- Lot codes and dates
517 of 517 codes
503173450342345034311503564050363335037019503792250379235039570504003350401625040476504119450433915043392504655450479415048106504810650499855051351505291350537245054982505618150566515057784505943250592995059931506418250641835064848506484950664345066634596760250676035076272503262250327585034233503431050356395037920503792150379305039572504016150433905046552504840750500595051349505134950663945067601507567650326235038026
- Amount recalled
- 9,782,880 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Tubing detachment
This product could cause temporary or reversible health problems — stop using it.
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