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CarolW
11-05-2008, 09:24 PM
Carolyn of the Muffin Pet Diabetes email list just called our attention to a recall, dated today, of one lot of ReiiOn insulin syringes.

I found the recall using Google, and here's the URL and a quote from the beginning of the page. I just posted this to the Muffin list.

This is my post:

Managed to find an FDA page on this. Here are two links to the same page:

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html

In case that breaks, here's a shorter version

http://tinyurl.com/6x28or

Here's the beginning of what it says there:



FOR IMMEDIATE RELEASE
November 5, 2008

Media Inquiries:
Siobhan DeLancey, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall applies to the following lot number and product information:

-- Lot Number 813900
-- ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin

Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.



That's probably enough information so anybody here who might be using the syringes can check to see if they have part of the recalled lot.

It's conceivable that people with large dogs might be using these syringes. Of course, also, that human diabetics could be using them on themselves!

And people using Vetsulin or Caninsulin, and converting measurements, could easily be using these syringes, too. So if you are using ReliOn syringes of 1 cc capacity, PLEASE CHECK YOUR LOT NUMBERS!

Carolyn - thanks SO MUCH for the heads-up!

Wed, 5 Nov 2008 21:10:51 (posted to Muffin]

Wed, 5 Nov 2008 21:23:01 (PST)

We Hope
11-06-2008, 06:17 AM
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html

FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall applies to the following lot number and product information:

-- Lot Number 813900
-- ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin

Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.

These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product.

The FDA urges patients and health care professionals to check their syringe packaging carefully for syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900.

Consumers and health care professionals who suspect they have the recalled product may also contact Covidien at 866-780-5436 or www.relion.com/recall for more information.

ReliOn Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle attached to the tip of the syringe.

During the packaging process for this lot, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin.

The manufacturer has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam's Clubs from Aug. 1, 2008, until Oct. 8, 2008.

Tyco Healthcare Group LP (Covidien) voluntarily recalled this lot of syringes on Oct. 9, 2008, asking that any units of the affected product be removed from inventory and placed in quarantine. Wal-Mart posted the recall announcement in Wal-Mart stores and Sam's Clubs, as well as on its Web site, and sent letters to more than 16,500 customers notifying them of the recall.

The manufacturer has received one adverse report related to a syringe from this product lot. Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

We Hope
11-13-2008, 07:20 AM
http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01081.html

FDA Enforcement Report November 12, 2008

PRODUCT
ReliOn Insulin syringes, 1cc, 31 G, Recall # Z-0284-2009

CODE
Lot number: 813900

RECALLING FIRM/MANUFACTURER
Recalling Firm: Ttco Healthcare Group, LP, Mansfield, MA, by letter on October 9, 2008.
Manufacturer: Covidien, LP, Norfolk, NB. Firm initiated recall is ongoing.

REASON
Mislabeled: Package labeled as an insulin syringe for use with U-100 insulin contains an insulin syringe for use with U-40 insulin. Risk of overdose of insulin.

VOLUME OF PRODUCT IN COMMERCE
471,000 needles or 4,710 boxes of 100

DISTRIBUTION
Nationwide