Device recall

Z-0897-2026: ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full…

FDA device recall · Class II · Cardinal Health 200, LLC

Key facts

Recall number (Z-number) Z-0897-2026
Recall event 97976
Product ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue…
Product code FYA
Recalling firm Cardinal Health 200, LLC
Recall class Class II
Status Open, Classified
510(k) numbers K193327
FEI number 3001236905

At a glance

  • 1–9 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)