Device recall

Z-2982-2011: Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per…

FDA device recall · Class II · North Coast Medi-Tek Inc

Key facts

Recall number (Z-number) Z-2982-2011
Recall event 59386
Product Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies
Product code LOR
Recalling firm North Coast Medi-Tek Inc
Recall class Class II
Status Terminated
Termination date Feb 16, 2012
510(k) numbers K854095
FEI number 1526414

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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