Device recall

Z-0986-2017: SafeStep Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN…

FDA device recall · Class II · Bard Access Systems

Key facts

Recall number (Z-number) Z-0986-2017
Recall event 76008
Product SafeStep Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted…
Product code FPA
Recalling firm Bard Access Systems
Recall class Class II
Status Terminated
Termination date Apr 17, 2017
510(k) numbers K040527
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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