Recall Z-2171-2017
Kci USA, Inc. · initiated April 28, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness burns, ulcers (such as Diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions they are 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. All exudates and infectious materials are collected in the canister
Codes / lots: 51020446, 51020448, 51020449, 51020750, 51020751, 51020752, 51020753, 51020856, 51021472, 51021936, 51021938, 51021939, 51021940, 51022283, 51022440, 51022441, 51022719
Reason for recall
Potential sterile barrier breach
FDA-determined cause: Packaging process control
Action taken
KCI sent an Urgent Voluntary Medical Device Field Notification letter to all affected consignees on April 28, 2017. KCI will monitor return of the Customer Reconciliation Forms to ensure compliance with the Field Notification. Customers were instructed locate and quarantine any of the affected product, complete Acknowledgement form and email to RegulatoryCompliance@acelity.com or fax to 210-255-6727. Customers with questions were advised to contact their local KCI Representative or KCI Customer Technical Support at 1-800-275-4524 and select Option 3 to arrange for return and replacement of the affected product.. For questions regarding this recall call 210-515-4108.
Details
- Recall number
- Z-2171-2017
- Initiated
- April 28, 2017
- Terminated
- February 1, 2018
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 5,385 cases
- Distribution
- Worldwide Distribution - US (nationwide) Internationally to Dominican Republic, Ecuador, Guatemala, Mexico, Panama, Austria, Estonia, Germany, Switzerland, Japan, and Malaysia
- Recalling firm
- Kci USA, Inc., San Antonio, TX