Renasys recall

Quote






There has been NO recall. It's just an improvement made to some products of the RENASYS family to enhance the product's performance. FDA only needs to clear the improvements made to Smith & Nephew's NPWT, which is a normal process that all product improvements or alterations go through in the US (FDA regulated).
 






Anonymous said:
There has been NO recall. It's just an improvement made to some products of the RENASYS family to enhance the product's performance. FDA only needs to clear the improvements made to Smith & Nephew's NPWT, which is a normal process that all product improvements or alterations go through in the US (FDA regulated).
Click to expand...

Uh...no.

1) FDA instructed S & N to cease distribution. No specific recall - but the FDA letter says stop selling the products.
2) This is not the process all companies go through. If it were there would be no issues. Apparently S & N made a number of changes that FDA believes require FDA pre-market approval for. This process did not happen. Apparently (if you read the letter - links abolve) there were numerous FDA requests for information regarding this (back to 2013) which were insufficient.

This was anything but normal. One or more folks in Quality and Regulatory must be feeling some significant heat just now. My guess is that this will be resolved - but I'd guess it's going to take several months to complete. OUCH !
 










































Anonymous said:
Hello everyone. There is not a Renasys recall. A very big misunderstanding by the FDA. It's all good.
Click to expand...

It's worse than a recall...according to the FDA any Renasys product is not to be used in the US. hospitals using it are at risk of any lawsuit. So we are supposed to ask for a letter of medical necessity? Asking that of a doctor for inpatient use is career suicide. Asking a doctor to bypass the FDA puts them at risk too.
 












Anonymous said:
It's worse than a recall...according to the FDA any Renasys product is not to be used in the US. hospitals using it are at risk of any lawsuit. So we are supposed to ask for a letter of medical necessity? Asking that of a doctor for inpatient use is career suicide. Asking a doctor to bypass the FDA puts them at risk too.
Click to expand...

The Certificate comes with the FDA's approval dummy. Go sell a via.
 






Anonymous said:
It's worse than a recall...according to the FDA any Renasys product is not to be used in the US. hospitals using it are at risk of any lawsuit. So we are supposed to ask for a letter of medical necessity? Asking that of a doctor for inpatient use is career suicide. Asking a doctor to bypass the FDA puts them at risk too.
Click to expand...

Ok KCI rep quit your fucking trolling.... U guys are so funny and so predictable- no wonder customers are willing to take on on these risks with the CMNs because you guys full of your own KOOL aid. Renasys works and the funny part about it is that customers would rather die than move their business back to you douchebags! If I were you I would worry about whether or not your DM knows where you are tomorrow and that you are making your daily order quota!
 


















Anonymous said:
It's worse than a recall...according to the FDA any Renasys product is not to be used in the US. hospitals using it are at risk of any lawsuit. So we are supposed to ask for a letter of medical necessity? Asking that of a doctor for inpatient use is career suicide. Asking a doctor to bypass the FDA puts them at risk too.
Click to expand...

Please tell me when the FDA has ever said that Renasys cant be used in a hospital. I'll wait.
 






Attention KMart shoppers, ATTENTION!
We have a blue light special on used overstocked Renasys on isle 6. Rock bottom 90% off retail @ $49.95 each. Great for desk paper weights, boat anchor, target practice and backyard mosquito traps.

And the KMART disclosure. *** Do not use on humans. May cause prolonged injury or possible greater harm.

Thanks,

Mgmt.
 


















WOCN here...have been following the latest talk regarding the Renasys because I placed one of these on a patient only to find out afterwards about the FDA hoopla. This site, thank you very much, actually helped me when I went back to my office to try to find some information. I then called the company to ask why the product was being distributed despite the FDA order and got the run around. I was not pleased. The company has a DUTY to inform consumers of this action and not try to let the vacs slide by. The rep did not think it was an issue and had to be reminded about the "no distribution" statement. Since I applied the vac that makes ME liable as well which quite frankly pisses me off. Very irresponsible business practice. Fortunately, I was able to get back to the pt and remove the device. Incidentally, if this is the new and improved Renasys keep it, it's a piece of crap. This is a coming from a person who has had to apply NUMEROUS vac dressings and no I don't work for KCI.
 






Top Bottom
Back
Quote