Thursday, June 14, 2012

J&J Recalls Catheters, Again.

J&J is recalling yet Another lot of Cordis, Fire Star (an aptly named product, considering the Reason it's being recalled) Catheters.

Mass Device has;
Cordis Issues "Urgent" Recall On Fire Star Balloon Catheters

You see, the units in question refused to deflate and had to be extracted by force. These suckers have been recalled before, in 2008. Here's the FDA notice.

Cordis Corporation Dura Star™ RX and Fire Star™ RX PTCA Balloon Catheters

Class 1 Recall
Date Recall
January 14, 2008
Fire Star™ RX and Dura Star™ RX PTCA Balloon Catheters
Products manufactured in Mexico from February, 2007 through December, 2007 and distributed worldwide from March 26, 2007 through January 8, 2008. Dura Star™ RX was distributed in the U.S. on August 29, 2007 and Fire Star™ RX was distributed in the U.S. on August 31, 2007.
All Fire Star™ and Dura Star™ lots 13173912 through 13315455, plus 52 additional lots above 13315455 are affected. (No lots above 13329055 are affected).
Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart.
Recalling Firm:
Cordis Corporation
14201 NW 60th Avenue
Miami Lakes, Florida 33014-2802
Reason for Recall:
The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure or death.
Public Contact:
Consumers with questions may contact Cordis, Inc. at 1-786-313-2000.
FDA District:
FDA Comments:
On January 14, 2008, a letter and an acknowledgement form were mailed to U.S. customers with a Cordis representative following-up requesting a signature of receipt. For non-U.S. customers, an email notice was sent with return acknowledgment to notify their distributors, who then contacted their customers in those countries. The company has consulted with the FDA about disposing the products.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.

Fierce Medical Devices will tell you;
J&J Cordis Recalls Balloon Catheters
The action affects a single lot of Cordis' Fire Star Rx dilation catheters, which wouldn't deflate properly

 "Johnson & Johnson ($JNJ) subsidiary Cordis is in the hot seat over its Fire Star Rx PTCA dilation catheters. The company has launched a recall of a single lot of the devices because of concerns over flawed deflation. Company spokeswoman Sandy Pound told MassDevice that 292 units are affected by the recall. All were distributed in China, India, Indonesia, South Korea and Taiwan, according to the story. So far, at least 8 adverse events involving the catheter have been reported to the FDA over March and April, though Pound is quoted as saying that no patients have died or been injured. Cordis dealt with a similar recall in 2008, according to the story. That was a Class I recall, which the FDA considers the most serious.

Related Articles:
Cordis appeals $40M award to Boston Sci
FDA clears Cordis' Empira catheters

According to the Mass Device article, someone named Pound, we're Assuming is J&J spokesperson Sandy Pound, is saying that This issue is not the Same issue which precipitated the 2008 recall. OK, so the product has been recalled twice for failure to deflate.

It's Doubly Defective and Cordis has had 4 Years to make sure it Does Deflate. Nice Product. Great Oversight. 4 years and they never saw this Different Failure to Deflate Issue while they were Fixing the Initial Failure To Deflate Issue.

And provided that Dr DSM Nutzo Drunk can find the correct end of the Defective Catheter, he'll just have to extract it by Force.

Study: 15% Of Surgeons Abuse Alcohol

And everyone Except these people, and a few More Classes of Government Employees, are Incurably Insane.

No comments: