Device recall

Z-3215-2011: Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle…

FDA device recall · Class III · Boston Scientific Corporation

Key facts

Recall number (Z-number) Z-3215-2011
Recall event 59743
Product Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Product code FCG
Recalling firm Boston Scientific Corporation
Recall class Class III
Status Terminated
Termination date Nov 10, 2011
510(k) numbers K100712, K110030
FEI number 3005099803

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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