Device recall

Z-0861-2010: Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site…

FDA device recall · Class II · Bard Access Systems

Key facts

Recall number (Z-number) Z-0861-2010
Recall event 53341
Product Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116. Safety IV administration set used to access surgically implanted vascular ports.
Product code FPA
Recalling firm Bard Access Systems
Recall class Class II
Status Terminated
Termination date May 14, 2010
510(k) numbers K993848
FEI number 3006260740

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1,000+ 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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