Monday, June 27, 2011

To: Homelite Corporation Re: Violation of ISO9001:2008 Section 8.2.3

To: Homelite Corporation
www.homelite.com

Model Number: vut21566

Serial Number: 0240643


Dear Homelite Corporation:

You have not followed up on my corrective action request number 11-061001 regarding the leaky priming bulb on the above weed whacker.

By your lack of response, you are in violation of ISO-9001:2008 section 8.2.3, lack of corrective action to remedy problems with the product.

Please advise ASAP your response to the above corrective action request. Failure to do so will place you in non-conformance with ISO standards, and is objective evidence that your quality system is not effective.

James A. Shell
RABQSA QMS-LA certified quality auditor #105245

Wednesday, June 22, 2011

Boston Scientific Stent Recall

More than 500 Boston Scientific Innova stents have been recalled because some have failed to deploy properly when inserted into patients. 
The Boston Scientific stent recall was announced on June 16 by the FDA, which classified the market withdrawal as a Class 1 medical device recall. The classification means that the FDA believes the defective stents carry a reasonable probability of causing serious injury or death to a patient.
The stents are used in the femoral and proximal popliteal arteries to treat symptomatic de novo or restenotic lesions. The recall comes following complaints to Boston Scientific that some of the stents failed to deploy when implanted in patients or only partially deployed.

http://www.aboutlawsuits.com/boston-scientific-innova-stent-recall-18971/
 Just when you think you've been having a really bad day, you get this call from your cardiologist....