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.
This recall has been terminated (originally issued May 10, 2011).
- Company
- Kci Usa, Inc.
- Recall Initiated
- February 18, 2011
- Posted
- May 10, 2011
- Terminated
- October 24, 2011
- Recall Number
- Z-2182-2011
- Quantity
- 229 units
- Firm Location
- San Antonio, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.
Distribution
Worldwide Distribution - USA and Kuwait.
Lot / Code Info
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.
Root Cause
Device Design
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.