Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
FDA device recall Z-2202-2014 · posted 2014-08-13 · Terminated
Recall details
- Recalling firm
- Gambro Renal Products, Incorporated
- Reason for recall
- Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
- Action taken
- Gambro sent an Urgent Field Safety Notice dated July 18, 2014 to all end-users. A Customer Reply Form was attached to the notice for customers to complete and return.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 401,451
- Distribution
- Worldwide Distribution.
- Date initiated
- 2014-07-18
- Date posted
- 2014-08-13
- Date terminated
- 2015-02-05
- 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 |