Device recall

Z-3024-2026: Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU…

FDA device recall · Class II · Medline Industries, LP

Key facts

Recall number (Z-number) Z-3024-2026
Recall event 99507
Product Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5) THORACIC, Medline Kit SKU DYNJ903470G; 6) CV PART 1 AND 2, Medline…
Product code LRO
Recalling firm Medline Industries, LP
Recall class Class II
Status Open, Classified
510(k) numbers K213481
FEI number 1417592

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)