Page 1 2 3 4 
Go
New
Find
Notify
Tools
Reply
  
Fresenius Recall
 Login/Join
 
posted
A week or so ago, the NaturaLyte (gallon bottles) we ordered for our acute programs did not come with our order. Fresenius was called and it was then that we were told that the products were on backorder. Now yesterday (SATURDAY!) Fresenius sends out an "Urgent Product Recall" for 107 Lot#'s of NaturaLyte and Citrasate for having low sodium levels.

I find it very interesting that a week or so prior to a recall the product goes on backorder. I can't help but think that Fresenius knew about the problem and either shipped all unaffected product or held it in reserve for their own clinics BEFORE even notifying anyone else.

Guess who's inventory is about 3/4 affected product? Keep in mind that our inventory was already low because of not receiving an order.

Since the recall wasn't issued till SATURDAY, we have to wait till Monday to try to arrange an alternate supply and hope that we can get it before running out completely.

I thought that every batch (lot) of concentrate had to be tested?
How did so many lots get through with the problem not being detected?
Why were customers not informed of the "backorder" (problem)?

I really hope that we start to see lawyers advertising for this like they did for Granuflo!

Chuck


DISCLAIMER : My opinions and views are mine and may not be the same as my employer.
 
Posts: 2118 | Location: Baltimore, MD USA | Registered: 24 October 2001Reply With QuoteReport This Post
<h2otech>
posted
We have not received any notification. Which is both a little irritating.
 
Reply With QuoteReport This Post
<Guest>
posted
We have not received notice of this yet. I went on FMC's website and can't find anything there either. I am having trouble with low conductivity on my machines using 2K2.0Ca. This is probably why. UGH!!!!
 
Reply With QuoteReport This Post
posted Hide Post
The information has been out, someone is not getting the information to you guys. I have been pulling lot#s since around the 17th of oct. They actually had to close the plant in Ohio until they found the issue. I have had all of my baths backordered as well and I work for the bigF.
 
Posts: 53 | Registered: 07 January 2020Reply With QuoteReport This Post
posted Hide Post
Here are the affected lot numbers I am aware of as of now...

08-3231-1: 20LXAC090

08-3251-9: 20LXAC058, 20LXAC043, 20LXAC044, 20LXAC045, 20LXAC059, 20LXAC030

08-2301-3: 20LXAC056, 20LXAC041, 20NXAC013

08-2251-0: 20LXAC076, 20LXAC049, 20LXAC048, 20LXAC047

08-2351-8: 20LXAC097

08-4231-0: 20LXAC052

08-2201-5: 20LXAC061, 20LXAC062, 20LXAC086, 20NXAC014

08-3201-4: 20LXAC038

08-3251-CA: 20LXAC051

08-1251-1: 20LXAC098

Also we found an additional bad lot previosuly unknown that I reported to fresenius last week..

08-3301-2: 20NXAC006


I drink and I fix machines, it's what I do...
 
Posts: 236 | Registered: 12 September 2016Reply With QuoteReport This Post
posted Hide Post
The additional one exhibited the same issues as the rest. I took a brand new unopened jug from the same box and tested it on a machine I had completed an annual on the day prior and saw the same results, a cond value of 13.3 on a machine with a tcd of 13.8.


I drink and I fix machines, it's what I do...
 
Posts: 236 | Registered: 12 September 2016Reply With QuoteReport This Post
posted Hide Post
quote:
Originally posted by BioMedKev:
Here are the affected lot numbers I am aware of as of now...

08-3231-1: 20LXAC090

08-3251-9: 20LXAC058, 20LXAC043, 20LXAC044, 20LXAC045, 20LXAC059, 20LXAC030

08-2301-3: 20LXAC056, 20LXAC041, 20NXAC013

08-2251-0: 20LXAC076, 20LXAC049, 20LXAC048, 20LXAC047

08-2351-8: 20LXAC097

08-4231-0: 20LXAC052

08-2201-5: 20LXAC061, 20LXAC062, 20LXAC086, 20NXAC014

08-3201-4: 20LXAC038

08-3251-CA: 20LXAC051

08-1251-1: 20LXAC098

Also we found an additional bad lot previosuly unknown that I reported to fresenius last week..

08-3301-2: 20NXAC006


You have more lots than me, though I expect and update this morning. Still not 107 that the OP said they received.
 
Posts: 53 | Registered: 07 January 2020Reply With QuoteReport This Post
<Guest>
posted
It would be nice if Fresenius would send out the recall notice to everyone so we aren't chasing our tails trying to figure out if something is wrong with our machine or not.
 
Reply With QuoteReport This Post
<pops>
posted
fill out a product complaint they will ask for the bad lots back cases only with rga and shipping label, still waiting for my rga and label Mad
 
Reply With QuoteReport This Post
posted Hide Post
neonblur,

If you were notified of it mid-October it pisses me off even more.

According to the recall letter dated November 7, there are 107 lots of affected product. The recall covers drums and bottles of both NaturaLyte and Citrisate.

If anyone wants the letter, leave your email.

Chuck


DISCLAIMER : My opinions and views are mine and may not be the same as my employer.
 
Posts: 2118 | Location: Baltimore, MD USA | Registered: 24 October 2001Reply With QuoteReport This Post
posted Hide Post
quote:
Originally posted by Chuck W, CDWS:
neonblur,

If you were notified of it mid-October it pisses me off even more.

According to the recall letter dated November 7, there are 107 lots of affected product. The recall covers drums and bottles of both NaturaLyte and Citrisate.

If anyone wants the letter, leave your email.

Chuck


Ok, that explains why you have so many lots. I have only received for the Naturalyte gallon jugs.
I think they will still add more lots seeing as how some of the floor techs have just been adjusting the alarm limits instead of reporting the low conductivity.
 
Posts: 53 | Registered: 07 January 2020Reply With QuoteReport This Post
posted Hide Post
quote:
Originally posted by neonblur:
The information has been out, someone is not getting the information to you guys. I have been pulling lot#s since around the 17th of oct. They actually had to close the plant in Ohio until they found the issue. I have had all of my baths backordered as well and I work for the bigF.


Do they have a plant in Ohio I thought it was Oregon and California?
 
Posts: 815 | Registered: 18 April 2009Reply With QuoteReport This Post
<ohiotech>
posted
Yes it's their plant in Oregon, Ohio that was affected.
 
Reply With QuoteReport This Post
<anon's face>
posted
I'm not sure why you're complaining. Fresenius became aware of a POTENTIAL issue with their naturalyte. A recall is never issued immediately. They sequestered the product they had until they could verify that such an issue existed, determined which lots, wrote up a recall, and sent it out. That's exactly how it should work. Why would they ship you product that could potentially be recalled, rather than just not ship the product until they determine the extent of the recall?
 
Reply With QuoteReport This Post
posted Hide Post
quote:
Originally posted by anon's face:
I'm not sure why you're complaining. Fresenius became aware of a POTENTIAL issue with their naturalyte. A recall is never issued immediately. They sequestered the product they had until they could verify that such an issue existed, determined which lots, wrote up a recall, and sent it out. That's exactly how it should work. Why would they ship you product that could potentially be recalled, rather than just not ship the product until they determine the extent of the recall?

You're not grasping the full extent of their mis-step. When our order was placed (almost 2 weeks before the recall was issued), we should have been told it was on backorder instead of having to wait a week and find out when the order didn't arrive. neonblur says they have known about the problem since the middle of October.

In they recall they also try to minimize how bad their screwup sounds by saying if the prescribed sodium level is 140 then the resulting dialysate sodium is only 1 mEq/L lower than normal serum level which they say is 135-145 mEq/L. While that's true its also not telling the full story...45X concentrate is designed to have a sodium level of 137 mEq/L (not 140). That puts the resulting sodium level down to 131 mEq/L which is well below "normal".

Now you have to take into consideration how the various dialysis machines actually work....
Fresenius machines - Strictly volumetric proportioning so it will result in a low conductivity but the other electrolytes will be unchanged. The low sodium can result in being VERY uncomfortable for the patient due to cramping but can also result in cardiac arrest.

Braun and Phoenix machines - Servo-controlled proportioning so the acid pump will speed up in order to maintain the proper conductivity. This also results in the other electrolytes being higher than they should be.

Are you starting to see the bigger picture?

Chuck


DISCLAIMER : My opinions and views are mine and may not be the same as my employer.
 
Posts: 2118 | Location: Baltimore, MD USA | Registered: 24 October 2001Reply With QuoteReport This Post
  Powered by Social Strata Page 1 2 3 4  
 


Copyright RenalWEB 2020