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U.S. Department of Health and Human Services

Class 2 Device Recall Elcam

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  Class 2 Device Recall Elcam see related information
Date Initiated by Firm February 02, 2017
Create Date April 20, 2017
Recall Status1 Open3, Classified
Recall Number Z-1869-2017
Recall Event ID 76446
510(K)Number K060231  
Product Classification Stopcock, i.V. Set - Product Code FMG
Product Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls


Product Usage:
indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Code Information Lot #1670350901
Recalling Firm/
Manufacturer
Elcam Medical, Inc.
2 University Plz Ste 620
Hackensack NJ 07601-6224
For Additional Information Contact
201-457-1120
Manufacturer Reason
for Recall
The stopcock was found to have punctures.
FDA Determined
Cause 2
Package design/selection
Action Elcam Medical sent their customers a recall letter/return response form dated February 2, 2017. Elcam is asking customers to examine their inventory for any affected products and to complete the return response form provided. For questions call 201-457-1120 ext. 102 or 201-457-1120 ext. 112.
Quantity in Commerce 810
Distribution U.S Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = FMG and Original Applicant = ELCAM MEDICAL A.C.A.L.
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