Date Initiated by Firm | November 20, 2018 |
Date Posted | May 15, 2019 |
Recall Status1 |
Terminated 3 on July 09, 2020 |
Recall Number | Z-1350-2019 |
Recall Event ID |
81610 |
510(K)Number | K113598 |
Product Classification |
Stretcher, wheeled - Product Code FPO
|
Product | Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000 |
Code Information |
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Recalling Firm/ Manufacturer |
Stryker Medical Division of Stryker Corporation 3800 E Centre Ave Portage MI 49002-5826
|
For Additional Information Contact | Victoria Haney 269-389-8306 |
Manufacturer Reason for Recall | The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be
broken. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Notification letters were distributed to customers on 11/20/18. |
Quantity in Commerce | 3285 |
Distribution | US Nationwide and the following foreign countries: Australia, Canada, Netherlands, South Africa, and Switzerland. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FPO
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