Date Initiated by Firm | February 02, 2017 |
Create Date | April 20, 2017 |
Recall Status1 |
Terminated 3 on June 08, 2018 |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FMG
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