FW: DSHS NOTICE: Heparin Adverse Events & Recalls

[Guest guest]

> Texas EMS/Trauma Systems Stakeholders:

>

> Vials of recalled heparin have been found during a routine health

> facility inspection here in Texas.

>

> Please see the heparin update notice below which includes instructions

> to check your inventory--including crash carts--for heparin and

> heparin-containing medical products to verify that they are not on the

> recall list. There is a DSHS contact person and telephone number in

> the note below, and also instructions to report any adverse patient

> reactions.

>

________________________________________________________________________

____________________________

> Update to Healthcare Facilities and Healthcare Professionals

> about Heparin and Heparin-containing Medical Products

>

> There has been an increase in the number of adverse events, including

> deaths, reported in association with the use of injectable heparin

> products. In particular, FDA has seen an increase in events consistent

> with an anaphylactic-type reaction and/or acute hypotension.

>

> Information on these events is available at

> http://www.fda.gov/cder/drug/infopage/heparin/adverse_events.htm.

> .

>

> Several manufacturers and distributors of heparin products have

> initiated recalls of their products based on reports of adverse events

> associated with their product(s) or as a precaution after testing

> revealed that they were supplied with contaminated lots of heparin.

>

> Further information on these recalls may be found at

> http://www.fda.gov/cder/drug/infopage/heparin/default.htm#recalls

> <http://www.fda.gov/cder/drug/infopage/heparin/default.htm> .

>

>

> Check your inventory, storage areas, carts, procedure rooms etc. for

> all heparin products, or products which contain or are coated with

> heparin and verify the product is not on the recall list

> http://www.fda.gov/cdrh/safety/heparin-device-list.html.

>

> Segregate any recalled product and contact Dr. Penfield at

> , or after 5 pm call and ask for the

> physician on call.

>

> Report any adverse patient reactions that may be associated with

> injectable heparin and heparin lock flush solutions, or with medical

> devices that contain or are coated with heparin to

> www.fda.gov/medwatch/report.htm and contact Dr. Penfield at

> , or after 5 pm call and ask for the

> physician on call.

>

________________________________________________________________________

____________________________

> STEVE JANDA, DIRECTOR

> OFFICE OF EMS/TRAUMA SYSTEMS COORDINATION

> TEXAS DEPARTMENT OF STATE HEALTH SERVICES

> OFFICE DIRECT

> 512-834-67OO MAIN LINE

> FAX

>

>