Device recall

Z-0537-04: Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction…

FDA device recall · Class II · Richard Wolf Medical Instruments Corp.

Key facts

Recall number (Z-number) Z-0537-04
Recall event 28227
Product Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wolf Ultrasound Lithotriptor used to disintegrate kidney stones, urinary bladder stones and ureter stones; Richard Wolf GmbH, D-75438 Knittlingen Germany
Product code JOL
Recalling firm Richard Wolf Medical Instruments Corp.
Recall class Class II
Status Terminated
Termination date Mar 24, 2004
510(k) numbers K011911
FEI number 1418479

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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