Device recall

Z-1105-04: Boston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile…

FDA device recall · Class II · Boston Scientific Corp

Key facts

Recall number (Z-number) Z-1105-04
Recall event 29476
Product Boston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile, single use only, model M001482501, REF/Catalog No. 48-250.
Product code DRE
Recalling firm Boston Scientific Corp
Recall class Class II
Status Terminated
Termination date Feb 11, 2005
FEI number 1828132

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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