Contact: Tim Schoenberg
Gambro Healthcare
Phone: (303) 231-4010
Fax: (303) 231-4915
1185 Oak Street
Lakewood, CO 80215

PRESS RELEASE

GAMBRO Healthcare Expands Recall for COBE
Centrysystem 3 Blood Tubing Sets & Hemodialysis Kits
Containing Blood Tubing Sets manufacturered by Gambro Healthcare

Lakewood, Colorado, June 10, 1998: GAMBRO Healthcare is announcing the immediate expansion of its May 25, 1998 lot specific recall of Catalog Number 003210-500 to all lots of COBE Centrysystem 3 Blood Tubing Sets for dialysis with the catalog numbers shown below, including Hemodialysis Kits containing blood tubing sets with these catalog numbers:

All Lot Numbers of Catalog Numbers:

003109-400	003109-410	003110-500	003111-500	003112-500
003113-500	003114-500	003210-500	003212-500	003101-000
003212515

Customers who have received these catalog numbers of blood tubing sets are being notified to immediately cease using them, quarantine any inventory, and arrange for their return to GAMBRO Healthcare. Replacement blood tubing sets will be sent to the dialysis facilities at once. Customers are being notified immediately by telephone and fax.

Use of these catalog numbers of blood tubing sets may be associated with incidents of hemolysis that have been reported in Nebraska, New Jersey, Alabama, Massachusetts, and Maryland within the past three (3) weeks. Hemolysis is the destruction of the red blood cells. A total of four patient deaths have been reported following dialysis treatment. Symptoms reported include abdominal pain, nausea, vomiting, cyanosis, chest pain, and flushing that occurred during and/or following dialysis treatment.

Special instructions are available for clinics which must provide treatment before replacements arrive and for which the only blood tubing sets available are those subject to the recall. Call GAMBRO Healthcare at (800) 456-7339 (24 hour) for these instructions.

GAMBRO Healthcare continues to work closely with the Food and Drug Administration and state health departments to investigate these reports. Every effort is being made to identify the root cause of the problem and to take aggressive actions that will prevent recurrence of these events.

GAMBRO Healthcare is urging anyone with information on possible dialysis-related hemolysis to contact GAMBRO Healthcare, Tim Schoenberg at (800) 525-2623 x4010.

[Contact Ray McNulty, Citigate Communications (212) 508-3400, Facsimile (212) 508-3541.]

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