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Terminated

Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm

FDA Recall Z-0817-2019 · Posted None

Recalling FirmAngiotech (Manan Medical Products, Inc.)
Recall StatusTerminated
Product CodeDWO
Date Initiated2018-12-18
Date Terminated2020-08-23
Product Quantity500 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.

K890925MANAN BONE MARROW BIOPSY NEEDLEManan Medical Products, Inc. · 1989-04-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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