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April 12, 2000

Urgent Warning to Hospitals and Hemodialysis Units - TriCitrasol May Cause Death

Washington, DC (SafetyAlerts) - The Food and Drug Administration is issuing an urgent warning to all hospital pharmacies and hemodialysis units that TriCitrasol, an unapproved product that has been used to keep bloodlines open, may cause death when infused into patients. TriCitrasol is marketed in individual, sterile, 30ml glass vials, distributed both individually and in hemodialysis kits.

FDA has learned that a patient died of cardiac arrest shortly after triCitrasol, a 46.7% concentration of sodium citrate anticoagulant, was injected full strength into a hemodialysis permanent blood access catheter that had just been implanted. Rapid or excessive infusion of citrate solutions can cause fatal heart rhythm disruption, seizures or bleeding due to loss of blood calcium.

Other incidents that may involve triCitrasol in the hemodialysis setting are under FDA review.

TriCitrasol is manufactured by Cytosol Laboratories, Braintree, Mass., and is distributed by Medcomp, Harleysville, Pa., and previously by Citra Anticoagulants, Inc. Both Cytosol Labs and Medcomp are voluntarily recalling triCitrasol for use with blood access catheters.

FDA is urging hospital pharmacies and hemodialysis units across the U.S. to stop using the product. Alternative 4% solutions of citrate are available for use in these and most other medical settings.

Because there is a need for this product in some procedures to prepare white cells for transfusion, FDA is working with the company to see that the product currently remains available for this use, which involves dilution.

In an April 9, 2000 letter to its customers, Medcomp announced a recall of its kits (or trays) containing triCitrasol and the Medcomp Ash Split Catheter II, for hemodialysis or apheresis, a blood separation and re-transfusion process. Approximately 3000 Medcomp catheter kits with triCitrasol were distributed nationwide. They were also distributed to Puerto Rico and Canada.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.