Reported Nov 9, 2016 · Terminated
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32",…
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 | SureT G29 6mm, 18", Paradigm |
| 2 | SureT G29 6mm 23" |
| 3 | SureT G29 6mm, 23", Paradigm |
| 4 | SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm |
| 5 | SureT G29 8mm, 23" |
| 6 | SureT G29 8mm, 23", Paradigm |
| 7 | SureT G29 8mm, 32" |
| 8 | SureT G29 8mm, 32", Paradigm |
| 9 | SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin |
- Lot codes and dates
251 of 251 codes
503878350404645042582504258450434145043415504663850466395047168504912250529035052904505668050572195057241505795350602055061496506369450644025068516506855550714035072333507368250755545076349504312150448435057215506414150685155035649503569050395785039579503958050395815040158504015950404655040466504046750404685042578504258050425815043094504309550431005043106504338750434175043418504341950463935046395504639650466405046641
- Amount recalled
- 4,748,000 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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