Severe FDA (Devices)·Z-0409-2013·Announced 2012-11-28

KCI RotoRest Delta Therapy System Head Pack Recalled for Skin Injury

KCI USA is voluntarily recalling 282 RotoRest Delta Therapy System head packs due to reports of skin breakdown and pressure ulcers.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves reported injuries ranging from Stage III to Stage IV pressure ulcers, which aligns with the rubric criteria for Severe severity (Class II with significant injury reports).

Plain-English summary

KCI USA, Inc. is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. The recall involves 282 units distributed nationwide, including to Alabama, California, Colorado, Oklahoma, and Georgia. The specific model number is 208030, and the affected serial numbers are 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.

The recall was initiated after KCI received complaints alleging that patients experienced skin breakdown on the head and face due to the positioning of the head pack. In a few instances, patients received injuries ranging from Stage III to Stage IV pressure ulcers.

Healthcare facilities and consumers should check their inventory for the specific model and serial numbers listed above. If the device is found, it should be removed from use and returned to KCI USA, Inc. according to the firm's instructions.

The recalled product

Product: 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
Manufacturer: KCI USA, Inc.
Category: Medical Device — Therapy System
Hazard: pressure-ulcer
skin-breakdown
Affected units: 282

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

Model Number 208030
Serial Numbers: 00157087
00157091
00157288
00157375
00157405
RRCKOO011
RRHKOO065
RRHKOO074
RRHKOO096
RRHK00109
and RRHKOO117.

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · KCI USA, Inc.

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