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U.S. Department of Health and Human Services

Class 2 Device Recall Endotrac ECTR Hook/Triangle Blade Kit

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  Class 2 Device Recall Endotrac ECTR Hook/Triangle Blade Kit see related information
Date Initiated by Firm April 30, 2019
Create Date June 20, 2019
Recall Status1 Terminated 3 on September 18, 2020
Recall Number Z-1848-2019
Recall Event ID 82894
510(K)Number K922391  
Product Classification Arthroscope - Product Code HRX
Product Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
Code Information Lot # 01410
Recalling Firm/
Manufacturer		 Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
For Additional Information Contact Elizabeth Beato
201-831-5838
Manufacturer Reason
for Recall		 The seal integrity of the sterile bag containing the kits may be compromised.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Recall notification letters dated 4/30/19 were sent to customers.
Quantity in Commerce 447
Distribution The products were distributed US nationwide.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = INSTRATEK, INC.
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