Recall Z-1131-2012
Hill-Rom, Inc. · initiated February 3, 2012
Product
Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized Therapy Unit provides a pressure-relieving sleep surface for patients in the home environment. It helps enable patients with pressure sores to heal their wounds
Codes / lots: The headboard (p/n 6020200003) and siderail (p/n 6020200002) are not serialized. There are no model, catalog or code number identification marks available on the accessories. It is possible to identify these accessories though by a mark stamped into the mounting post that are used to attach these accessories to the bed. May 2011 and October 2011 headboards and siderails were shipped to customers.
Reason for recall
The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed outer rail, which is extruded Aluminum tubing, is intended to be one piece joined together by a weld at the lower center. The parts receiv
FDA-determined cause: Nonconforming Material/Component
Action taken
Hill-Rom, Inc. sent a Modification Notice Urgent Medical Device Correction Notification dated February 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The modification notice instructed all customers to find and replace all headboards and food side rails that do not meet design intent. All technicians will inspect all affected product in the service centers and all at home and rite hite beds for an "x" or "L" stamp. The technicians will inspect the beds that are still in use during scheduled maintenance or before each rental. All will be completed before 01-JUL-12. For support call 1-800-445-3720
Details
- Recall number
- Z-1131-2012
- Initiated
- February 3, 2012
- Posted by FDA
- March 1, 2012
- Terminated
- December 5, 2012
- Product code
- INX – Bed, Air Fluidized
- Quantity
- Foot Siderail = 70; Headboards = 103
- Distribution
- Worldwide Distribution -- USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY. and the country of Canada.
- Recalling firm
- Hill-Rom, Inc., Batesville, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1132-2012 | Clinitron Rite Hite Bed headboard and foot side rails. The Clinitron Rite Hite Air…The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards… | 02/03/2012Terminated |