Class 2 Device Recall MRVLS 4W GXL: W1/R RBLS

• Date Initiated by Firm: July 19, 2015
• Date Posted: September 10, 2015
• Recall Status: Terminated on September 18, 2017
• Recall Number: Z-2748-2015
• Recall Event ID: 71880
• 510(K)Number: K122953
• Product Classification: Pump, infusion, insulin - Product Code LZG
• Product: Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.
• Code Information: Elcam Part Number: 572808; lot numbers: 1270243601, 1070181601, 1170205601, 1070178501, 1070181601, 1070178501 Elcam Part Number: 572452; lot numbers: 0870106101, 1070153401,1070157001, 1070174301, 1070178202, 1070178201, 1070181701, 1070181702, 1170188001, 1170201801, 1170206001, 1270215901, 1270217601, 1270219801, 1270225801, 1270227101, 1270227102, 1270227801, 1270228901, 1270235401, 1270235401, 1270237801, 1270241101, 1270248001, 1270248002,1370249601, 1370250401, 1370258101, 1370264101, 1370267501, 1370270901 Elcam Part Number: 573302; lot numbers: 0970142301, 0970146701, 1070153301, 1070159201, 1070164501, 1070170301, 1070171501, 1070180301, 1070182401, 1170185501, 1170185502, 1170188301, 1170189701, 1170190601, 1170198101, 1170203902, 1170210801, 1170203901, 1270214701, 1270214702, 1270217301, 1270221801, 1270223201, 1270229001, 1270239701, 1270245101, 1270247901, 1270247902, 1370249501, 1370252801, 1370252802, 1370258601, 1370265101, 1370265102, 1370270501, 1370273601, 1470287901, 1470288401, 1470289801, 1470290901, 1470290902, 1470298101, 1470300201, 1470302101, 1470303401, 1470305101, 1470305102, 1470305702, 1470305703, 1470305701, 1470307401, 1470310801, 1470310802, 1470310803, 1470314101 Elcam Part Number: 571403; lot numbers: 0970128401, 0970131801, 1070158201, 1070159101, 1070160901, 1070164401, 1170197001, 1170197002, 1170207501, 1270214301, 1270214302, 1270217401, 1270223101, 1270228201, 1270232901, 1270240801, 1270245701, 1370251901, 1370254301, 1370265701, 1370273501, 1370275901, 1470288801, 1470290401, 1470290402, 1470295201, 1470299201, 1470306001, 1470311201, 1470313401 Elcam Part Number: 571803; lot numbers: 0870102901, 1070158101, 1070159001, 1070161501, 1070161502, 1070162501, 1070162502, 1170185001, 1170188101, 1170195201, 1170195202, 1270214401, 1270225701, 1270232801, 1270232802, 1270236201, 1270236202, 1270244001, 1370254401, 1370272801, 1370282301, 1470296301, 1470297301, 1470299301, 1470308101, 1570320201, 1570321901
• FEI Number: 3003649401
• Recalling Firm/ Manufacturer: Elcam Medical, Inc.; 2 University Plz Ste 620; Hackensack NJ 07601-6224
• For Additional Information Contact: Ms. Miriam Lerner; 201-457-1120
• Manufacturer Reason for Recall: Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
• FDA Determined Cause: Packaging
• Action: Elcam Medical sent "Urgent: Stopcock Recall" notices and "Recall Return Response Forms" dated 7/19/2015 to their customers. The recall notification informed the customers of the reason for the recall and the actions they must take. Customers were instructed to cease distribution and quarantine any affected products; return to Elcam Medical the enclosed Recall Return Response Form; and notify their customers as per their recall procedures.
• Quantity in Commerce: 7,721,580 units
• Distribution: Texas, New Mexico and Pennsylvania
• 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 = LZG