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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 Elcamsee related information
Date Initiated by FirmFebruary 02, 2017
Create DateApril 20, 2017
Recall Status1 Terminated 3 on June 08, 2018
Recall NumberZ-1869-2017
Recall Event ID 76446
510(K)NumberK060231 
Product Classification Stopcock, i.V. Set - Product Code FMG
ProductElcam 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
ActionElcam 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 Commerce810
DistributionU.S Nationwide Distribution
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.
510(K) Database510(K)s with Product Code = FMG
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