Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton
FDA device recall Z-2199-2014 · 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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRISMA M60/M100 SETS (K032431) | Gambro, Inc. | 2003-09-15 |