Device recall

Z-0777-06: Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized…

FDA device recall · Class II · Medline Industries, Inc.

Key facts

Recall number (Z-number) Z-0777-06
Recall event 35123
Product Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case; Manufactured for Medline Inductries, Inc., Mundelien, IL 60060 U.S.A., Made in…
Product code LRO
Recalling firm Medline Industries, Inc.
Recall class Class II
Status Terminated
Termination date May 9, 2006
FEI number 3000717925

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

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