BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or diff

FDA device recall Z-2466-2012 · posted 2012-09-27 · Terminated

Recall details

Recalling firm

KCI USA, Inc.

Reason for recall

KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The BariAir Therapy System is not designed to allow the patient to place the bed into the patient exit position. KCI has received complaints indicating that patients used the hand pendent to inadvertently place the BariAir Therapy System into a pseudo-exit position. In a small number of instances, this allow

Action taken

KCI sent an Urgent - Voluntary Medical Device Correction letter dated September 13, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers would be contacted by KCI to coordinate a shipment of a replacement product. For questions customers would instructed to call 1-800-275-4524, Select Option 3 followed by Option 2. For questions regarding this recall call 1-800-275-4524.

Root cause

Device Design

Status

Terminated

Product code

FNL

Quantity affected

575

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.

Date initiated

2012-09-17

Date posted

2012-09-27

Date terminated

2013-07-29

Location

San Antonio, TX