The Scotsman
Well-Known Member
Wed Nov 5, 2008 7:06pm EST
WASHINGTON (Reuters) - U.S. health officials warned doctors and patients on Wednesday that Covidien Ltd was recalling nearly half a million single-use syringes that could pose a serious risk to diabetics.
The Food and Drug Administration said the possibly mislabeled ReliOn syringes could lead to patients receiving an insulin overdose of as much as 2.5 times the intended dose, leading to low blood sugar levels and serious health consequences, including death.
During the packaging process, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin.
Wal-Mart Stores Inc sold the syringes at Wal-Mart stores and Sam's Clubs from August 1 until October 8, the FDA said.
Covidien voluntarily recalled the syringes on October 9, asking that any units of the affected product be removed from inventory and placed in quarantine, the agency said.
Wal-Mart posted the recall announcement in Wal-Mart stores and Sam's Clubs, as well as on its website and sent letters to more than 16,500 customers notifying them of the recall.
The FDA said the manufacturer has received one adverse report related to a syringe from the lot numbered 813900.
Consumers and health care professionals who suspect they have the recalled product may contact Covidien at 866-780-5436 or
http://www.relion.com/recall/ for more information.
http://www.reuters.com/article/domesticNews/idUSTRE4A500Q20081106