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U.S. Department of Health and Human Services

Class 2 Device Recall PowerPRO 2

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  Class 2 Device Recall PowerPRO 2 see related information
Date Initiated by Firm February 01, 2023
Date Posted March 15, 2023
Recall Status1 Open3, Classified
Recall Number Z-1256-2023
Recall Event ID 91716
Product Classification Stretcher, wheeled - Product Code FPO
Product Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location.
Model: 650705550001
Code Information GTIN: 07613327559118 Serial Numbers: 2208002066, 2208002071, 2209001508, 2208001664
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information Contact SAME
269-389-8306
Manufacturer Reason
for Recall		 Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.
FDA Determined
Cause 2		 Under Investigation by firm
Action Stryker issued Urgent Medical Device Correction letter dated 2/1/23. Letter states reason for recall, health risk and action to take: 1. Locate the units listed on the attached business reply form and remove them from service until repairs are complete. 2. Return the enclosed business reply form to confirm receipt of this notification by fax +1 269 488 8691 or email productfieldaction@stryker.com. 3. Stryker will contact you to arrange for the modification/repair of your Power-PRO 2. 4. If you have loaned or sold or disposed of any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. Questions or concerns, contact Customer Service at +1 800 327 0770 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.
Quantity in Commerce 4 units
Distribution US Nationwide distribution in the states of NY, VA.
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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