Device recall

Z-0229-2016: Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom…

FDA device recall · Class II · Resource Optimization & Innovation Llc

Key facts

Recall number (Z-number) Z-0229-2016
Recall event 72053
Product Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
Product code LRO
Recalling firm Resource Optimization & Innovation Llc
Recall class Class II
Status Terminated
Termination date Apr 6, 2017
FEI number 3004513970

At a glance

  • None 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

Browse all FDA device recalls (products)