Device recall

Z-1608-2013: Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access…

FDA device recall · Class II · Greatbatch Medical

Key facts

Recall number (Z-number) Z-1608-2013
Recall event 65464
Product Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV Elastomeric Infusion…
Product code DYB
Recalling firm Greatbatch Medical
Recall class Class II
Status Terminated
Termination date Aug 4, 2014
510(k) numbers K110051
FEI number 2183787

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

Browse all FDA device recalls (products)