Device recall

Z-0058-2007: Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only…

FDA device recall · Class II · Cardinal Health

Key facts

Recall number (Z-number) Z-0058-2007
Recall event 36421
Product Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico The cardiovascular drapes were packagaged under the following configurations: a) Catalog #9158 - 1 CV split drape b) Catalog #9158CE - 8 x 1 CV split drape
Product code KKX
Recalling firm Cardinal Health
Recall class Class II
Status Terminated
Termination date May 9, 2008
FEI number 3001236905

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

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