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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Angiotech (Manan Medical Products, Inc.): 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

Agency Publication Date: February 7, 2019
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Affected Products

Product: "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Model Number IMKBMN-11R-10-X, Lot Numbers LJUE, LEAC, LFKX; Model Number IMKBMN-11R-10, Lot Numbers LK0J, LEHU

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Product: J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Model Number IMKBMN-13R-10, Lot Numbers LF69, LFDA, LFL1

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Product: J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Model Number IMKBMN-13R-6, Lot Number LFD9

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

Model Number BMNJ-MEC-1110, Lot Number LHT1

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Product: Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Model Number UCIN-16-5, Lot Number LK2L

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Product: Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm

Model Number UCIN-11-10, Lot Number LFDB

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Product: Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Model Number UCIN-15-5, Lot Number LJ2T

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81968
Status: Resolved
Manufacturer: Angiotech (Manan Medical Products, Inc.)
Manufactured In: United States
Units Affected: 7 products (9,900 units; 1,260 units; 180 units; 500 units; 1,404 units; 2,502 units; 504 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.