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.
FDA Recall Z-2748-2015 · Posted 2015-09-10
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Recalling FirmElcam Medical, Inc.
Recall StatusTerminated
Product CodeLZG
Date Initiated2015-07-19
Date Terminated2017-09-18
Product Quantity7,721,580 units
Reason for Recall
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
Firm 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.
Root Cause
Packaging
Distribution Pattern
Texas, New Mexico and Pennsylvania
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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