This is a pretty large recall and it is obviously devices used at the hospital.  The reason for concern is pretty serious if the device malfunctions as an air embolism imagewould pretty much either kill you or bring you close to it.  

In reading below this includes almost a year’s worth of manufactured products.  The issue has been corrected on products since this time and the company has a listing of the lot numbers for everyone to look up and see if they have any of the products in their facilities.  This is a mess as the catheter system is something commonly used.  We are talking millions of products if I am reading this correctly below. 

What would have made this process easier:

Tags for Use in Healthcare – Medical Stents, Medications - One Scan Away From Safety Information in Real Time

I know I keep hammering away at this but it’s the solution, especially since all the recalled products were distributed world wide.  Imagine anyone in any country using a Smartphone, BlackBerry or Iphone to just scan a tag on the device and having the option to scan a Tag online to see if it was one of the recalled products if you went the other way around with looking a a description page of the device.  We like to make things complicated here and do not like change.  If this had been in place think of how much easier the process would be, and if there’s any doubt if a hospital registry did not get all the products removed, use the phone and scan in 30 seconds.  I should probably send this link to Becton Dickinson for their consideration since the FDA has deaf ears.  As mentioned before, the Tags are free so it’s just a matter of time to create them.  As mentioned before a grocery store chain figured out how to protect consumer safety with recalled products, but I guess it’s tech denial and maybe the word change again.  Even hospitals in other countries could easily scan and determine the devices had been recalled.  

How Does a Grocery Store Chain Kick the FDA, Pharma and Healthcare in the Butt When It Comes to Recalls

Here’s the webpage on the Becton Dickinson site for the lot and model numbers.  BD

Franklin Lakes, NJ (NewYorkInjuryNews.com) – The Food and Drug Administration (FDA) www.fda.gov has announced that Becton, Dickinson and Company (BD) has voluntarily recalled certain lots of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems due to the potential hazard that the device may cause an air embolism or leak blood, which can result in injury or death.

The company sent out a worldwide letter that alerted professionals of the hazard risk with the devices. The Q-Syte Luer Access device was used with other fusion therapy products to give fluids intravenously. The Nexiva product, which contains two BD Q-Syte devices, also became a part of this recall after the first recall in October 28, 2009 due to a potential manufacturing deviation. The catalog numbers and the lot numbers for the U.S. and internationally, involved in the recall may be found on the FDA’s website under Safety recalls, market withdrawals, and safety alerts at http://www.fda.gov/Safety/Recalls/UCM200121.

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BD announced the recall to protect patients across the world after there were complaints received about how air had entered the bottom disk of the septum. The company determined that the problem was found to be a manufacturing issue. The products were distributed from November 2008 through November 2009. The company has fixed the manufacturing issue and continues to take preventative measures such as additional inspections. There were a reported 2.8 million BD Q-Syte and 2.9 million BD Nexiva units with 5 million BD Q-Syte devices that were sold in the U.S. Asia, Europe, Mexico, Canada, the Middle East, South America and South Africa. The company continues to work with the FDA to continue recalls.

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Professionals with questions may contact BD at 1-800-453-4538, option 2, extension 2585, Monday through Friday between 8:00 a.m. and 5:00 p.m. or directly at 1-801-565-2300, x2585 or x2860. For serious reactions to the quality problems with the devices, contact FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm

New York Injury News- FDA Alert: BD announced recall of medical devices due to potential hazard - New Jersey

1 comments :

  1. I agree with the tagging. Simply publishing a list of the recalled style and lot number is not enough to ensure the safety of the people around the world. Could you imagine how many people use Catheters everyday? And that's around the world! BD and the FDA is simply not doing enough to take care of the issue.

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