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U.S. Department of Health and Human Services

Class 2 Device Recall KCI RotoProne Critical Care Therapy

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  Class 2 Device Recall KCI RotoProne Critical Care Therapy see related information
Date Initiated by Firm February 18, 2011
Date Posted May 10, 2011
Recall Status1 Terminated 3 on October 24, 2011
Recall Number Z-2182-2011
Recall Event ID 58466
Product Classification Bed, patient rotation, powered - Product Code IKZ
Product 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.
Code Information Serial numbers: RRFK0036-RRFK00047; RRFK00049-RRFK00115; RRFK00117-RRFK00128; RRFK00141-RRFK00211; RRFK00213-RRFK00233; RRFK00235; RRFK00237-RRRFK00254; RRFK00256-RRFK00261; RRFK00263-RRFK00267; RRFK00269-RRFK00270; RRFK00273-RRFK00280; RRFK00282-RRFK00284; RRFK00287-RRFK00290; and RRJK00002.
Recalling Firm/
Manufacturer		 KCI USA, Inc.
4958 Stout Dr
San Antonio TX 78219-4334
For Additional Information Contact
210-255-5571
Manufacturer Reason
for Recall		 Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 229 units
Distribution Worldwide Distribution - USA and Kuwait.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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