Device recall

Z-0081-2007: Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage…

FDA device recall · Class II · Boston Scientific Corp

Key facts

Recall number (Z-number) Z-0081-2007
Recall event 36439
Product Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350.
Product code FFA
Recalling firm Boston Scientific Corp
Recall class Class II
Status Terminated
Termination date May 3, 2007
510(k) numbers K944290
FEI number 1828132

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

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