Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
FDA Recall Z-0818-2019 · Posted None
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Recalling FirmAngiotech (Manan Medical Products, Inc.)
Recall StatusTerminated
Product CodeDWO
Date Initiated2018-12-18
Date Terminated2020-08-23
Product Quantity1,404 units
Reason for Recall
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Firm Action
Argon Medical Devices notified customers on about 12/18/2018 via "Urgent - Field Safety Notice" letter. Instructions included complete and return the response form a quickly as possible, return all affected product to their Argon Wheeling facility, and to provide the recall notification to all who need to be aware within the organization as well as any organization where the affected product was distributed.
Root Cause
Equipment maintenance
Distribution Pattern
Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
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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