Vacuette, Safety Blood Collection Set with Luer Adapter
FDA Recall Z-0797-03 · Posted 2003-05-09
Recalling FirmGreiner VACUETTE North America
Recall StatusTerminated
Product CodeJKA
Date Initiated2003-03-10
Date Terminated2003-08-07
Product Quantity139000 units
Reason for Recall
The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.
Firm Action
Consignees were notified via certified letter on/about 3/6/2003 and were advised to stop distributing the product immediately and to discard any remaining product in stock.
Root Cause
Other
Distribution Pattern
Product was distributed to medical facilities Nationwide.
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.