FDA Device

Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.

Hazard

A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.

What You Should Do

Remedy

Consignees were notified by letter on 05/16/2006.

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Products

Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
Brand
Gambro Renal Products, Inc.
UPC
Serial numbers: PA0101 to PA0681.

Units Affected

153 units (US)

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