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Gambro Healthcare

Urgent recall: Cobe Centrysystem3 blood tubing sets (outbreaks of hemolysis)

FDA Medwatch (May) May:May 25 1998

This is the retyped text of a press release from Gambro Healthcare.

GAMBRO Healthcare
Renal Care Products

PRESS RELEASE

For Immediate Release

Company Contacts:

Mats Wahlstrom, Telephone Number: 303-231-4950
John R. Chappell, Telephone Number: 303-2055-2618

URGENT RECALL: COBE CENTRYSYSTEM 3 BLOOD TUBING SETS

Dateline: Lakewood, Colorado; May 25, 1998

Gambro Healthcare, Inc. headquartered in Lakewood, Colorado, is announcing the immediate and urgent recall of COBE Centrysystem 3 Blood Tubing sets with the Part Number 003210-500 and Lot Numbers of 04D15308, 04D15309, AND 04D15310. Gambro Healthcare is notifying the four (4) distributors and thirty-one (31) affected dialysis clinics, beginning immediately, by telephone. It is critical and urgent that dialysis clinics using the COBE Centrysystem 3 blood tubing sets immediately remove from use the blood tubing sets with the part number and lot numbers shown above. Gambro Healthcare is urging dialysis clinics to contact their satellite clinics and affiliated home dialysis patients and provide them with this information. If the home patients have any of the three lot numbers, please arrange for them to receive replacements blood tubing sets immediately.

Use of these lot numbers of blood tubing sets are believed to be the cause of outbreaks of hemolysis, a destruction of the red blood cells, reported within the last week in six hemodialysis clinics located in Maryland, Nebraska, and Massachusetts. Two deaths have been reported in Maryland following dialysis treatment. Symptoms reported include abdominal pain, cyanosis, chest pain, and flushing that occurred during and/or following dialysis treatment.

Gambro Healthcare is working with customers now, by telephone, to replace these lots with lots unaffected by the defect. The defect is believed to be caused by a partial blockage in the arterial side of the blood tubing set which may result in hemolysis of the blood.

Gambro Healthcare urges anyone with information on possible dialysis-related hemolysis to contact Gambro Healthcare Customer Information Center at 1-800-456-7339.

Gambro Healthcare has been working closely with the US Food and Drug Administration, the Centers for Disease Control and Prevention, and state health officials to investigate these reports. Every effort is being made to identify the root cause of the defect and to take actions that will prevent any such reoccurrence in the future.

The management and staff of Gambro Healthcare are shocked and saddened by these events. Our hearts go out to the families and friends of the people who have been adversely affected.

[Contact Ray McNulty, Citigate Communications (Memorial Day only: (203) 259- 3688; otherwise (212) 508-3400, Facsimile (212) 508-3541.]

This press release has been reproduced from the FDA Medwatch site. The original can be found at this link.