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U.S. Department of Health and Human Services

Class 2 Device Recall 6381 M1 Cot Fastener

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 Class 2 Device Recall 6381 M1 Cot Fastenersee related information
Date Initiated by FirmMarch 09, 2018
Create DateMay 02, 2018
Recall Status1 Terminated 3 on April 09, 2019
Recall NumberZ-1599-2018
Recall Event ID 79817
Product Classification Stretcher, wheeled - Product Code FPO
Product6381 M-1 Cot Fastener, catalog no. 6381000000
Code Information Serial No. 170740538  170740539  170740540  
FEI Number 1831750
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information ContactVictoria Haney
269-389-8306
Manufacturer Reason
for Recall		The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
FDA Determined
Cause 2		Labeling Change Control
ActionOn March 9, 2018, the recalling firm notified affected distributors of the issue via their electronic product field action management system, who in turn notified their customers through written communication. Customers were informed of the issue and instructed to do the following: 1. Locate the operations manual shipped with each unit listed on the attached business reply form and replace it with the corrected manual included with the letter. Dispose of the incorrect manual. 2. Return the enclosed business reply form to confirm receipt of this notification to productfieldaction@stryker.com 3. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise the firm of their new location in the space provided on the business reply form. 4. If you have disposed of any of these units, advise the firm of their obsolescence by providing the firm with their serial number in the space provided on the business reply form.
Quantity in Commerce3
DistributionProduct distributed to the Netherlands
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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