Device recall

Z-1083-05: Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit…

FDA device recall · Class II · Teleflex Medical

Key facts

Recall number (Z-number) Z-1083-05
Recall event 32627
Product Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box; Rusch, 2450 Meadowbrook Pwy, Duluth, GA 30096, Assembled in Mexico from U.S. Components…
Product code FCM
Recalling firm Teleflex Medical
Recall class Class II
Status Terminated
Termination date Nov 14, 2007
510(k) numbers K010420
FEI number 3004959265

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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