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Terminated

KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.

FDA Recall Z-2182-2011 · Posted 2011-05-10

Recalling FirmKCI USA, Inc.
Recall StatusTerminated
Product CodeIKZ
Date Initiated2011-02-18
Date Terminated2011-10-24
Product Quantity229 units

Reason for Recall

Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.

Firm Action

Firm sent a letter with the "Warning: Improper Insertion of the RotoProne Therapy System Buckle Can Lead To Unintentional Bed Exit" to all consignees on 2/23/2011. The letter identified the affected product and the reason for the recall. Customers were instructed to read the attached product warning regarding the proper method to attach the RotoProne buckles and to post it with the device to ensure continued proper use of the buckles. If customers had questions regarding the proper use of the buckles, they were to contact KCI Customer Technical Service at 1-800-275-4524.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA and Kuwait.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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