Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
FDA device recall Z-0032-2007 · posted 2006-10-12 · Terminated
Recall details
- Recalling firm
- Gambro Renal Products, Inc.
- Reason for recall
- 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.
- Action taken
- Consignees were notified by letter on 05/16/2006.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 153 units (US)
- Distribution
- Nationwide.
- Date initiated
- 2006-05-16
- Date posted
- 2006-10-12
- Date terminated
- 2012-01-03
- Location
- Lakewood, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS (K041005) | Gambro Renal Products | 2004-10-07 |