RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
This recall has been terminated (originally issued November 20, 2012).
- Company
- Kci Usa, Inc.
- Recall Initiated
- June 27, 2012
- Posted
- November 20, 2012
- Terminated
- April 22, 2013
- Recall Number
- Z-0409-2013
- Quantity
- 282 units
- Firm Location
- San Antonio, TX
- Official Source
- View on FDA website ↗
Reason for Recall
The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.
Distribution
Nationwide Distribution including AL, CA, CO, OK and GA.
Lot / Code Info
Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.
Root Cause
Component design/selection
Action Taken
KCI sent an Urgent - Voluntary Medical Device Correction letter dated June 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that KCI would contact them soon to coorinate a shipment of a replacement of the affected product. For any questions customers were instructed to call 1-800-275-4524, Selection Option 3 followed by Option 2. For questions regarding this recall call 1-800-275-4524.