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Class 2 Device Recall Pro Surface |
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Date Initiated by Firm |
June 24, 2022 |
Create Date |
July 20, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1413-2022 |
Recall Event ID |
90511 |
Product Classification |
Bed, flotation therapy, powered - Product Code IOQ
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Product |
Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01. |
Code Information |
UDI 00887761977860, Serial numbers: W214BP3955, W214BP3956, W243BP4436, W243BP4438, W243BP4445, W243BP4446, W243BP4447, and W243BP4448. |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield IL 60015-4625
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For Additional Information Contact |
Center for One Baxter 800-422-9837
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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.
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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 |
8 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
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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.
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