Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Pro Surface

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Pro Surface see related information
Date Initiated by Firm June 24, 2022
Create Date July 20, 2022
Recall Status1 Open3, Classified
Recall Number Z-1417-2022
Recall Event ID 90511
Product Classification Bed, flotation therapy, powered - Product Code IOQ
Product Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
Code Information UDI 00887761977914; Serial numbers: W238BP4349, W238BP4350, W238BP4352, W238BP4354, W238BP4355, W238BP4356, W238BP4357, W238BP4358, and W238BP4359. 
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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
Quantity in Commerce 9 mattresses
Distribution 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.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-