PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manag
FDA device recall Z-1140-2014 · posted 2014-03-05 · Terminated
Recall details
- Recalling firm
- KCI USA, INC.
- Reason for recall
- Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
- Action taken
- KCL sent an Urgent Voluntary Medical Device Correction letter dated February 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate, quarantine and return the affected device. For a replacement of the affected product and questions customers were instructed to contact KCL Customer Technical Support at 1-800-275-4524. A Product Reconciliation Form is attached to be completed and returned.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 20,850 units total
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2014-01-30
- Date posted
- 2014-03-05
- Date terminated
- 2015-04-06
- Location
- San Antonio, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING (K123878) | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2013-01-15 |
| PREVENA INCISION MANAGEMENT SYSTEM (K100821) | Kci USA, Inc. | 2010-06-11 |