Z-2748-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2015
- Initiation Date
- July 19, 2015
- Termination Date
- September 18, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,721,580 units
Product Description
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.
Reason for Recall
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
Distribution Pattern
Texas, New Mexico and Pennsylvania
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