Heparin recall

[lovemypts]

Don't know all about it, but we are under a recall. Something about a recall on 1000u bottles. Anyone else know what it about. I know, I am an employee, but we are the last to know. What is it about. How far spread. Watch and ask!!

[Roadrunner]

Hi,

I found two items in yesterdays news on a heparin recall. Doesn't it seem strange that two companies should produce bad batches?  Maybe they are the same company.  There are so many subsidiaries.

• Representatives from the drug maker, Indiana-based Baxter Healthcare, are on their way to HealthPark Medical Center to investigate.
  
  During the past week, the company has been receiving calls about allergic-type reactions the heparin. spokeswoman Erin Gardiner said. It has launched an investigation.  “The cause is not yet known, but we are taking swift reaction,” she said.
  
  The company Thursday issued a voluntary recall of nine batches of heparin. Heparin can cause allergic reactions, but company officials were concerned about the high number of calls they received, Gardiner said.  The drug is distributed nationwide.

•   January 18, 2008 07:34 PM Eastern Time
  B. Braun’s Supplier Prompts Voluntary Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flush Syringes
  
  AM2PAT Inc. manufactures these pre-filled syringes under both its private label, Sierra Pre-Filled Inc., as well as under the B. Braun Medical Inc. label
  
  BETHLEHEM, Pa.--(BUSINESS WIRE)--B. Braun Medical Inc. was recently notified by its contract manufacturer, AM2PAT Inc., of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes.
  
  The voluntary removal affects the following B. Braun branded Pre-filled Heparin and Saline Flush Syringes manufactured by AM2PAT:
                 Catalog #              Lot #                   Description
                                
           513584          All             Normal Saline 3mL in 12 mL Syringe
           513586          All             Normal Saline 5mL in 12 mL Syringe
           513587          All             Normal Saline 10mL in 12 mL Syringe
           513610          All             10 units/mL Heparin, 5mL in 12 mL Syringe
           513611          All             100 units/mL Heparin, 3mL in 12 mL Syringe
           513612          All             100 units/mL Heparin, 5mL in 12 mL Syringe
  
  Customers that have the recalled product in their possession should discontinue use immediately.
  

Roadrunner

[glitter]

the last week dialysis has been rough- they had 10 people a shift vomiting, including my husband- he does not usually do that at dialysis- then alot of crashes on wed. -- they had called and asked everyone to take benedryl before their shift while they were trying to figure out the problem...then friday one of the nurses told my husband he had been given (along with everyone else) Heparin that was recalled- and possibly that is the cause for all this ...

[lovemypts]

wow< sounds more like contamination of the heparin shouldn"t there be something of the fda site or maybe renalweb?  keep your eyes and ears open

[Roadrunner]

The FDA has just added this to the recall.


FDA: Heparin, saline syringes recalled

WASHINGTON, Jan. 23 (UPI) -- The U.S. Food and Drug Administration announced a nationwide recall of ALL lots and sizes of Braun Medical Inc. pre-filled heparin and saline flush syringes.

Braun, the distributor of the syringes, was notified by its contract manufacturer, AM2PAT Inc., of the recall due to a safety issue.

An investigation by the Centers for Disease Control and the FDA determined the syringes might be contaminated with Serratia marcescens -- a type of bacteria that can produce life-threatening injuries or death.

The FDA said customers that have the recalled product in their possession should discontinue use immediately and contact the Braun customer support department at 800-227-2862 to learn how to handle the affected products and to arrange for a replacement.

[tamara]

Found a Baxter recall in my travels surfin the net tonight. News release from 25/01/08

http://www.baxter.com/about_baxter/news_room/news_releases/2008/01-25-08-heparin_multi.html