Device recall

Z-2641-2024: Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a…

FDA device recall · Class II · Microtek Medical Inc.

Key facts

Recall number (Z-number) Z-2641-2024
Recall event 94780
Product Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Product code KPE
Recalling firm Microtek Medical Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K811234
FEI number 3014342658

At a glance

  • 1–9 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)