Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
Recall
- Recall Number
- Z-1415-2022
- Event Number
- 90511
- Firm
- Baxter Healthcare Corporation
- FEI Number
- 1417572
- Product Code
- IOQ
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 24, 2022
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
Description
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.
The recalling firm issued a Medical Device Correction Letter dated 6/24/2022 via UPS on 6/24/2022. The letter described the problem, the potential risk, and the actions to be taken by the user. The actions were to inspect their product and check for any indication of error codes present. Identification of error codes were described depending on the configuration of the consignee's product. If the consignee detects an error code, they are to contact the Hillrom Technical Support to have the PRO+ Surface corrected. A list of affected serial numbers was attached to the letter as Appendix 1. Distributors were instructed to share the notification with their end users. A response form was attached to be completed and returned within 2 weeks to confirm they have reviewed and understand the attached letter and that distributors have shared the notification with their end users and will complete the field action
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NM, NM, NY, OH, OK, RI, SD, TN, TX, VT, and WI. There was government distribution but no military distribution. The country of Canada.
136 mattresses