Device recall

Z-0489-2019: Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model…

FDA device recall · Class II · Merck Millipore Ltd.

Key facts

Recall number (Z-number) Z-0489-2019
Recall event 81122
Product Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon clinical sample concentrators are for in vitro diagnostic use and are intended for…
Product code JJH
Recalling firm Merck Millipore Ltd.
Recall class Class II
Status Terminated
Termination date Aug 5, 2021
FEI number 1000532580

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)