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U.S. Department of Health and Human Services

Class 2 Device Recall Reprocessed HoverMatt Air Transfer Mattress

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  Class 2 Device Recall Reprocessed HoverMatt Air Transfer Mattress see related information
Date Initiated by Firm June 21, 2023
Date Posted August 11, 2023
Recall Status1 Open3, Classified
Recall Number Z-2394-2023
Recall Event ID 92655
Product Classification Device, patient transfer, powered - Product Code FRZ
Product HoverMatt, 39" W x 78" L, REF: HM39SPU-B
Code Information UDI-DI: 07613327487718, Lot: 0000185127, Distribution Dates: 11/28/2022-12/08/2022
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information Contact
888-888-3433
Manufacturer Reason
for Recall		 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort exerted by staff for a lateral patient transfer, and there may be increased friction and shearing forces when the patient is moved resulting in skin tear injury.
FDA Determined
Cause 2		 Packaging process control
Action On 6/21/23, recall notices were distributed to customers who were asked to do the following: 1) Return affected devices. 2) Complete and return the Business Reply form to SSSPFA@stryker.com 3) If any of the affected product have been forwarded to additional facilities (including but not limited to distribution warehouses), contact these facilities and communicate this recall to them and instruct them to complete and return the Business Reply Form. Adverse reactions or quality problems can be reported to the Complaint Hotline: +1-888-763-8803 or http://www.stryker.com/productexperience
Quantity in Commerce 340
Distribution US: WI, ID, CA, FL, HI, MD, RI, AZ, MA, GA, IL
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.
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