# ACCU-CHEK? FlexLink Plus infusion sets Recall



## mikeinspain (Feb 25, 2011)

Hi everyone.. Just some info for anyone using FlexLink infusion sets.

Roche announces recall of ACCU-CHEK? FlexLink Plus infusion sets.. 
The US FDA link is http://www.fda.gov/Safety/Recalls/ucm244487.htm

Now whether this affects the UK/Europe market, I can not say but I would certainly suggest getting in touch with Roche/Accu-chek directly or DSN/HCP as soon as possible to clarify and hopefully provide some reassurance.

Hope that helps


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## Jennywren (Feb 25, 2011)

I have just looked on Accu-chek uk and cant find any recall message , thanks for advice tho its always best to check things like this out


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## mikeinspain (Feb 25, 2011)

Jennywren said:


> I have just looked on Accu-chek uk and cant find any recall message , thanks for advice tho its always best to check things like this out


Hi 

I would not worry to much about the Accu-cheek website, but contact them directly via telephone.  Quoting the FDA recall notice.

Mike


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## Ergates (Feb 25, 2011)

You can't order any more flex link plus as of last Tuesday, and the notices are supposed to be out by Monday coming.


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## SilentAssassin1642 (Feb 26, 2011)

Oh gosh! I use those ones, never had a problem. Am actually running out of them. I should phone them, cuz am worried now...

edit lol i forgot its saturday so tried ringing them and got a right snotty woman on the end of the line who had no clue and said she would get Roche to call me on Monday. I doubt they will  

Thankfully I've got the old flex links in the cupboard should I run out. If they don't call on Monday, I'll call them because I think they've forgotten about my "standing order" anyway, and I need some cartridges. Then I'll ask what to do about the flex link plus...because I'm worried. And I love those infusion sets


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## Jennywren (Feb 26, 2011)

Will ring roche on monday too , have noticed a rise in blood sugars just lately thought it was due to stress


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## Twitchy (Feb 28, 2011)

Oh my goodness, I've been pulling my hair out last week, needing 6 set changes in 5 days, did wonder if it was a batch issue or something?!  Had stupidly swinging levels for no obvious reason, hypo to high teens, feeling seriously grot!  Phonecall to Roche methinks!... Thanks for the heads up.


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## Northerner (Feb 28, 2011)

I'm surprised they don't inform people by email in this day and age (as well as using other media, of course)


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## Pumper_Sue (Feb 28, 2011)

Can I ask that if you have faulty sets for any reason be it non sticking bent cannula etc you ask that the company concerned replaces the sets free of charge to your PCT. Those sets cost ?10 a time.
My attitude is why should we the tax payer pay for their faulty goods. We don't put up with it in normal shopping/goods.


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## Ellie Jones (Feb 28, 2011)

I'm afriad it's seems to be a case of having to phone Rouche customer services if you use the flexlink plus!

As no information on their website, and as yet a recall/problems hasn't been logged with the MRHA (alert being published)

It seems that the FDA is a lot quicker and perhaps more tighter than their counterparts in Europe or UK!  Does make you wonder, as well there are drugs that had their licence withdrawn by the FDA but still being used here!


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## Jennywren (Feb 28, 2011)

*Have spoken to Roche Customer Service*

Spoke to roche this afternoon , those people using flexi link should receive a letter tomorrow  .They are recalling all the flexi link infusion sets , although the uk has not had a problem other coutries have and just to be on the safe side thgey are recalling .They are saying you need to speak to your dsn to see what alternative they recommend , then they will send you an envelope to return flexi link and provide alternative or you can carry on using flexi link if you are happy to , but when you need new ones they will be different .Waiting now for my dsn to ring me back to see what she suggests .


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## Jennywren (Feb 28, 2011)

Maybe anyone on flexi link should give Roche a call


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## Ergates (Mar 1, 2011)

The letter came through this morning, and when I phoned Roche for something else, they were so busy with calls the whole company was busy taking messages for the order department.  LOL!  I feel a bit sorry for the employees when you get a massive rush on like that.

I'm going to carry on using my flexlink plus for now before going onto the older model, I'm happy with them, and have had no problems.  No additional cost to the PCT as a result.


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## Ellie Jones (Mar 1, 2011)

Ergates

Don't worry about the PCT, as they won't face any additional costs, it will be Rouche who will pay the costs...


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## Ergates (Mar 1, 2011)

I think only if you return the unused flexlink plus, which is fair enough.


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## ThunderBolt (Mar 1, 2011)

Jennywren said:


> They are saying you need to speak to your dsn to see what alternative they recommend.



Had a feeling this might happen...  Just read the email from DSN and she said...  Ring Roche...  Magic!


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## Twitchy (Mar 3, 2011)

Well finally seem to have a good reason for haywire results last week - what I though was an ok cannula today 'went off' (for want of a better expression) at work, luckily I'd put 3 spare in my bag (thinking paranoia as I've needed to change at least once almost every day the past week or so!). With their letter in hand I put the first cannula in the linkassist & cocked it - it didn't look like it had the required distance between the needle cut & top of cannula that they described in the recall letter - so off it went...cannula number two had the needle cut immediately adjacent to the cannula, so obviously didn't use that one, luckily cannula 3 seemed to have a decent separation - all three were from the same batch!  This cannula has been working fine.

I did contact Roche again about returns, basically its only in quantities of 10 (ie box-worths) and then the hospital will be refunded.  Anything like the cannulas I described above that already failed or were clearly not to design won't / can't be refunded, which is a bit of a disappointment really, just seems the nhs is paying for their suppliers' problem...  Anyway, after gathering together my tens, I've six left over of the FLplus infusion sets (with tubing) 2 each of 3 different batches, so it will be interesting to see how those are - I can't remember if I've had problems with these cannulas but it will be interesting to see how they look now I know what I'm looking for.  I did also suggest to Roche that they include a scaled drawing in future manuals / training info so we all know what is 'normal' and can flag up anything that seems wrong in future.

Fun fun fun...my poor old tum looks like I decided to go for a polka dot print tattoo lol!


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## Jennywren (Mar 4, 2011)

Spoke to dsn on monday as she suggested the older flexi link cannulas , i have had no trouble tho so will continue using the flexi link plus until i run out .


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## SilentAssassin1642 (Mar 4, 2011)

I thought i would try the old flex links seeing as how i'm almost out of the new ones...putting them in manually isn't very nice  but I'll have to put up and shut up for a bit i think


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## Jennywren (Mar 4, 2011)

SilentAssassin1642 , you dont have to they do a device that inserts the flexi link too they sent me one with the old cannulas ,it is a bit old looking to the flexi link plus device but its worth it if you dont like inserting manually


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## SilentAssassin1642 (Mar 4, 2011)

Jennywren said:


> SilentAssassin1642 , you dont have to they do a device that inserts the flexi link too they sent me one with the old cannulas ,it is a bit old looking to the flexi link plus device but its worth it if you dont like inserting manually



problem being im never at home to get parcels, so not much point in me ordering something only for the post office to send it back :/ The recall shouldn't last for long, so I can put up with it. Its not so bad once you've done it once or twice, takes me a whikel to get the strength to do it but meh


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## Ellie Jones (Mar 5, 2011)

Rouche is quite happy to deliver your parcel to a place of your choice, either work or another residental address as long as somebody is able to sign for it! If your employer isn't very forth coming about having personal items posted to work for you, perhaps your partners company might be more accomandating!

Flexilink and Tenderlinks (latter not the angled ones) do have an inserter that you can have, it's a bit of a bulky thing though to carry around, so have a word with Rouche/DSN about this..

Or perhaps have a look at different manufacturers that use the lunar connector system as these will fit the Spirit Combo, again ask your DSN about these..

I actually use the tenderlink angled sets, and do self insert which I haven't found a problem with doing this, I feel that I am more in control with my insertion process I've little to no fat layer to insert so able to angle them a lot better, so fair in the 3 years I've been using the tenderlink I've not had one kinked cannular, I've had next to zero problems with the tenderlink which I sure wouldn't be the case if I used the inserter...


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## tracey w (Mar 5, 2011)

Ellie i also use tenderlink, self insertion cannulas. So far i have never had a kinked or bent cannula either.

The only problem i sometimes find is if i exercise hard they can get a bit of blood in cannula. I used to remove immediately but have found a small prime seems to work fine. Not saying that they should not be removed but just saying they are fine when i have done this. Obviously i have tested etc.


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## Twitchy (Mar 8, 2011)

I seem to have had a load of kinked cannulas compared to you guys?!  Not sure if that's down to the design problem or my wrecked mummy tummy though?!  Guess I'll need to try the standard flexlinks to see - I had more or less just concluded that it was just inevitable to get the odd kinked cannula - it's really encouraging to see it might not be!


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