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U.S. Department of Health and Human Services

Class 2 Device Recall Dynarex CPR Shield With One Way Valve

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  Class 2 Device Recall Dynarex CPR Shield With One Way Valve see related information
Date Initiated by Firm July 02, 2014
Date Posted July 25, 2014
Recall Status1 Terminated 3 on April 20, 2017
Recall Number Z-2117-2014
Recall Event ID 68681
510(K)Number K052743  
Product Classification Valve, non-rebreathing - Product Code CBP
Product CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China.

Used as a physical barrier for mouth to mouth resuscitation.
Code Information Lot Numbers 28619 & 28621
Recalling Firm/
Manufacturer		 Dynarex Corporation
10 Glenshaw St
Orangeburg NY 10962-1207
Manufacturer Reason
for Recall		 "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.
FDA Determined
Cause 2		 Employee error
Action Voluntary Device Recall letters (dated 7/01/14) and recall verification forms were sent to customers via US Postal First Class Mail on 7/02/14. The letters instructed customers to check their inventory for the specific lots, discontinue distributing them, and quarantine them immediately. Customers were to promptly contact Dynarex Credit & Return Representative Avi Celnick at 1-845-365-8200 ext. 6644 to arrange for product return and obtain an RGA #. For questions, please call Dynarex's toll free number 1-888-396-2739.
Quantity in Commerce Domestic: 208 cases; Foreign: 42 cases
Distribution Worldwide Distribution -- USA, Canada, and Mexico.
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 = CBP and Original Applicant = DYNAREX CORP.
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