Reported Nov 9, 2016 · Terminated
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs;…
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?
8 of 8 products
| # | Product as published |
|---|---|
| 1 | AC TenderLink 13/30 10 pcs |
| 2 | AC TenderLink I 13/60 10 pcs |
| 3 | AC TenderLink I 13/80 10 pcs |
| 4 | AC TenderLink I 17/110 10 pcs |
| 5 | AC TenderLink I 17/30 10 pcs |
| 6 | AC TenderLink I 17/60 10 pcs |
| 7 | AC TenderLink I 17/80 10 pcs |
| 8 | AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin |
- Lot codes and dates
91 of 91 codes
503243350336545037164504041950443625046682505130850532985058508506192750622025065546506929750722525075118504435950532895061929503243650336575037159504042050443555046683505130950532995058501506192850622055065539506929550722495032442503366250371625040424504436150513045053292505850550619315061933506220850324385037160504436050513105053300506221150692965072253503243950324405033659503366050371615040422504436550466845051303
- Amount recalled
- 653,280 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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