Device recall

Z-0258-04: Irrigation aspiration system with double spike tubing and 33 cm probe, latex…

FDA device recall · Class II · Vital Concepts, Inc.

Key facts

Recall number (Z-number) Z-0258-04
Recall event 27694
Product Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog # 55060. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.
Product code BYY
Recalling firm Vital Concepts, Inc.
Recall class Class II
Status Terminated
Termination date Sep 13, 2004
510(k) numbers K934382
FEI number 1000115375

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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