Device recall

Z-1097-2011: Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic…

FDA device recall · Class I · Cook, Inc.

Key facts

Recall number (Z-number) Z-1097-2011
Recall event 57663
Product Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double Lumen, 9.5Fr/15cm, CUDLMY953JABRMFST, G13481, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
Product code FOZ
Recalling firm Cook, Inc.
Recall class Class I
Status Terminated
Termination date Jun 21, 2011
510(k) numbers K081113
FEI number 1820334

At a glance

  • 1–9 Linked 510(k)s
  • 100–999 Products in the same recall event
  • 100–999 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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