Reported Nov 9, 2016 · Terminated
Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43",…
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?
13 of 13 products
| # | Product as published |
|---|---|
| 1 | Infusion Set, Comfort, 23" Hosp 10 |
| 2 | Comfort 13mm, 23", STD 5/5 |
| 3 | Comfort 13mm, 23" Hosp 10 |
| 4 | Infusion Set, Comfort, 43", Hosp 10 |
| 5 | Infusion Set, Comfort, 31", Hosp 10 |
| 6 | Comfort 13mm, 31". Hosp 10 |
| 7 | Infusion Set, Comfort, 23", STD 5/6 |
| 8 | Comfort 13mm, 43" Hosp 10 |
| 9 | Infusion Set, Comfort 43", STD 5/5 |
| 10 | Infusion Set, Comfort Short, 13mm x 23" |
| 11 | Infusion Set, Comfort Short, 13mm x 32" |
| 12 | Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43" |
| 13 | Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin |
- Lot codes and dates
148 of 148 codes
502124750212515021253502981350318195031820503182150318225031823503257750325785033752503375350337545033755503406250340635034064503419950342005035085503508650350985035099503510050370245037025503810650381075038108503810950381105040382504093950409405040941504094250409435040944504094550409465041053504105450410555041056504105750438205044874504487550448765044877504487850448795044880504488150448825047110504711150471125047113
- Amount recalled
- 1,295,515 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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