Recall Z-1135-2014
Kci USA, Inc. · initiated January 30, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Codes / lots: Kit Lot #'s 2363893, 2367890, 2368876, 2368877, 2379870, 2382869, 2389874, 2397884, 2406889, 2410933, 2411866, 2417879, 2423890
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
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-1135-2014
- Initiated
- January 30, 2014
- Posted by FDA
- March 5, 2014
- Terminated
- April 6, 2015
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 20,850 units total
- Distribution
- USA Nationwide Distribution
- Recalling firm
- Kci USA, Inc., San Antonio, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1136-2014 Class II | PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | 01/30/2014Terminated |
| Z-1137-2014 Class II | PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | 01/30/2014Terminated |
| Z-1138-2014 Class II | PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | 01/30/2014Terminated |
| Z-1139-2014 Class II | PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | 01/30/2014Terminated |
| Z-1140-2014 Class II | PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | 01/30/2014Terminated |
| Z-1141-2014 Class II | PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage:…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | 01/30/2014Terminated |
| Z-1142-2014 Class II | PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | 01/30/2014Terminated |