Device recall

Z-0938-2011: Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by…

FDA device recall · Class II · Flowcardia Inc.

Key facts

Recall number (Z-number) Z-0938-2011
Recall event 50791
Product Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA Intended use: Catheter for use in surgery.
Product code DQY
Recalling firm Flowcardia Inc.
Recall class Class II
Status Terminated
Termination date Jan 25, 2011
510(k) numbers K072776
FEI number 3005007189

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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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