Device recall

Z-2321-2008: Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply…

FDA device recall · Class II · Medline Industries Inc

Key facts

Recall number (Z-number) Z-2321-2008
Recall event 48749
Product Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100% cotton sponges, 10 sponges per pack, 80 packs per case; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA, Made in China; reorder: NON21432RF
Product code GDY
Recalling firm Medline Industries Inc
Recall class Class II
Status Terminated
Termination date Jan 9, 2009
510(k) numbers K061316
FEI number 1417592

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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