Device recall

Z-0069-2018: AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.

FDA device recall · Class II · Windstone Medical Packaging, Inc.

Key facts

Recall number (Z-number) Z-0069-2018
Recall event 78366
Product AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Product code LRO
Recalling firm Windstone Medical Packaging, Inc.
Recall class Class II
Status Terminated
Termination date Jul 2, 2018
FEI number 1000125955

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)