VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
FDA Recall Z-0835-2013 · Posted 2013-02-15
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Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeFMI
Date Initiated2013-02-01
Date Terminated2013-10-29
Product Quantity192,000 pieces (192 cases)
Reason for Recall
The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
Firm Action
Greiner Bio-One sent a notification letter dated January 31, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to stop distributing the affected product, complete the attached Product Disposition form and fax to GBO at 800-726-0052 or email to [email protected]. GBO will contact customers for the return of the affected product after receiving the attached Product Disposition form. Customers were requested to provide the names of customers who may have received the product. For questions call 800-515-8112.
Root Cause
Other
Distribution Pattern
US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA
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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