Wheeling, IL, United States
Angiotech (Manan Medical Products, Inc.) recalls
1 recall recorded since 2018, most recently on 18 December 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 December 2018
- Terminated
- 23 August 2020
- Reason
- 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
- Distribution
- Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0818-2019, Z-0819-2019, Z-0816-2019, Z-0820-2019, Z-0815-2019, Z-0814-2019, Z-0817-2019
- Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
- J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.