KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209

FDA device recall Z-2182-2011 · posted 2011-05-10 · Terminated

Recall details

Recalling firm

KCI USA, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

IKZ

Quantity affected

229 units

Distribution

Worldwide Distribution - USA and Kuwait.

Date initiated

2011-02-18

Date posted

2011-05-10

Date terminated

2011-10-24

Location

San Antonio, TX