Device recall

Z-0261-04: Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with…

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

Key facts

Recall number (Z-number) Z-0261-04
Recall event 27694
Product Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand
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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