Renasys recall

Goodbye NPWT.

 

What happened?!

 

I just got word from corporate that all the Renasys units and the disposables are being recalled due to a government regulation. All Renasys products are frozen until further notice.
This will be at least a 2 to 3 month fix.

Get out the resume, commissions will not be happening.

 

When will customers be notified?

 

Customers should be receiving the recall notice in the next week. Accounts will be extremely mad. We don't have a back up plan except some cool looking gauge. Maybe a hoover vacuum cleaner might work in the meantime.

Heck, a Hoover might do a better job than our pump since I have seen so many failed wounds on the Renasys.

Just keeping it real.

 

No product has been recalled. All products have not been frozen. Stop.

 

Wow, I just heard Medtronic totally thumbed their nose at buying us since they merged with Covidien. Medtronic got cold feet when they heard about the massive recall on the Renasys and related product.

This is just getting worse by the minute.

The titanic is going down.

Guess I should have taken swimming lessons.

 

Recall Event ID 67479
Recalling Firm/
Manufacturer Smith & Nephew Inc.
970 Lake Carillon Dr
Ste 110
Saint Petersburg, Florida 33716-1130

Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation causing significant

 

that's not good.

URGENT: MEDICAL DEVICE NOTICE

Smith & Nephew is providing this notice to advise users of its RENASYS EZ and RENASYS EZ Plus Negative Pressure Systems of a design flaw bacterial overflow guard (filter) introducing air leakage in the vacuum circuit during system set-up and operation.

Device users are reminded that reports of adverse events experienced with medical devices should be reported to FDA’s MedWatch Adverse Event Reporting program. Reports may be made online, by fax or by mail. Information regarding the MedWatch program and reporting instructions are available on FDA’s website at http://www.fda.gov/MedicalDevices/default.htm

 

Well its been fun while it lasted.

 

Wasnt this from a long time ago, when we fixed the canisters? This isnt a new recall. Neither is the other one about the pooling. All old news.

 

Play it down all you want but there was a negative event reported to the FDA. This is NOT a voluntary recall and there is no quick fix. Inspection into claims, lawsuits and the inevitable commercials stating "if you have ever used this product, call us" S&N will drop biotherapeutics like its a hot rock. warm up the resume and please exit the vehicle

 

When is the recall going to happen? I have established great relationships with my WOCN's when are we going to tell the hospitals? I want them to hear it from us, not the Internet or a competitor.

 

If you worked for smith & nephew you wouldn't be asking these questions. Stop spewing venom. The product has not been recalled.

 

What are you talking about? There is something going on they pulled all of our Renasys products off the website. It better it come from us and not competitor.

 

14 is clueless. Being announced today. BANG!!!

 

You sound pretty confident. So, if there isn't a product recall announcement today, you'll come back on here and post an apology and your name right? BANG

 

I just went to FDA's website and found the Medical Device Recall page and see the page was updated with today's date (6-19-14). The most recent Renasys recall notices were the ones from March of this year and they have the same description but it wasn’t for the system but just for the kits. (There was more than one recall since it is by lot numbers and catalog number). Those were recalls but it doesn’t appear that the products were even needed to be returned to S&N and instead a notice was sent out to customers. Not that severe of a Recall….

If what you describe is a new Recall and people are already hearing about it…. then why is this recall not even on FDA’s website yet? The FDA updates their Recall pages DAILY.

Where did those notices copied and pasted in the above posts come from? Not from FDA. ( Makes me think they were faked.)

 

I found where this post came from. It was from S&N's own site and it was an Recall from November of last year (11/2013). This was for the canisters and those products were not required to be returned either.

"No removal of product distributed to the market is required and all canisters and bacterial overflow guards supplied by Smith & Nephew for use with RENASYS EZ/RENASYS EZ Plus systems can be used safely if they are used in accordance with the instructions in the supplied user manual."

 

Okay this is definitely faked. I looked up "Recall Event ID 67479" and it is for PARSNIPS! Food! Recalling firm is Ed Feild & Sons. Gee Wiz!