MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.
FDA Recall Z-2870-2016 · Posted 2016-09-22
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Recalling FirmGlobal Healthcare Inc
Recall StatusTerminated
Product CodeFMI
Date Initiated2016-08-09
Date Terminated2017-01-23
Product Quantity282 cartons (1000 units per carton)
Reason for Recall
The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.
Firm Action
The distributors were first notified on August 9, 2016 via phone to place product on hold. They were notified of the recall on August 10, 20l6 by email.
Root Cause
Under Investigation by firm
Distribution Pattern
FL
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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