Device recall

Z-2960-2011: Bard Aspira Dressing Kit, Product Code 4991503. The Aspira Peritoneal Drainage…

FDA device recall · Class III · Bard Access Systems

Key facts

Recall number (Z-number) Z-2960-2011
Recall event 59119
Product Bard Aspira Dressing Kit, Product Code 4991503. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other…
Product code FJS
Recalling firm Bard Access Systems
Recall class Class III
Status Terminated
Termination date Nov 2, 2011
510(k) numbers K110396
FEI number 3006260740

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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