Device recall

Z-1623-2021: Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF…

FDA device recall · Class II · Bioseal Corporation

Key facts

Recall number (Z-number) Z-1623-2021
Recall event 87636
Product Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
Product code KDD
Recalling firm Bioseal Corporation
Recall class Class II
Status Completed
FEI number 2027062

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)