Recall Z-0820-2019— Angiotech (Manan Medical Products, Inc.)

Name: FDA recall Z-0820-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-18

Class II · Terminated

Class II FDA medical device recall by Angiotech (Manan Medical Products, Inc.), initiated 2018-12-18, terminated 2020-08-23. It names one FDA 510(k) clearance: K890925. Product: Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.. 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.

Recalling firm: Angiotech (Manan Medical Products, Inc.)
Classification: Class II
Status: Terminated
Initiated: 2018-12-18
Terminated: 2020-08-23
Firm location: Wheeling, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K890925 — MANAN BONE MARROW BIOPSY NEEDLEManan Medical Products, Inc.·cleared 1989-04-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.