Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure moni...
FDA Device Recall #Z-2748-2015 — Class II — July 19, 2015
Recall Summary
| Recall Number | Z-2748-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 19, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Elcam Medical, Inc. |
| Location | Hackensack, NJ |
| Product Type | Devices |
| 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
Lot / 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
Other Recalls from Elcam Medical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1869-2017 | Class II | Elcam Minimal Residual Volume Luer-activated Sw... | Feb 2, 2017 |
| Z-2749-2015 | Class II | Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Ma... | Jul 19, 2015 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.