Device recall

Z-1430-06: Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure…

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

Key facts

Recall number (Z-number) Z-1430-06
Recall event 35845
Product Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, disposable, single use accessory to the TEM (Transanal Endoscopic Microsurgery) System used for…
Product code HIF
Recalling firm Richard Wolf Medical Instruments Corp.
Recall class Class III
Status Terminated
Termination date Jun 15, 2007
510(k) numbers K000180
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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