StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.
FDA Recall Z-0925-03 · Posted 2003-06-12
Recalling FirmVenetec Intl Inc
Recall StatusTerminated
Product CodeFPA
Date Initiated2003-05-12
Date Terminated2003-10-14
Product Quantity3150 units
Reason for Recall
Set tubing disconnected from the male luer lock during use on patients. Misassembled.
Firm Action
A recall letter was sent to the distributor who then sent thier own letters to the affected hospitals. Hospitals were reached on or about May 14, 2003 whereas the distributor was contacted by telephone and letter on or about May 12, 2003. It was verbally agreed that the distributor would subrecall the product.
Root Cause
Other
Distribution Pattern
One distributor sent the product to 6 hospitals in the states of CT, IN, PA, TN.
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.