Device recall

Z-0359-06: Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is…

FDA device recall · Class II · Sandhill Scientific, Inc

Key facts

Recall number (Z-number) Z-0359-06
Recall event 34222
Product Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.
Product code FAP
Recalling firm Sandhill Scientific, Inc
Recall class Class II
Status Terminated
Termination date May 15, 2006
510(k) numbers K931175
FEI number 2023374

At a glance

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

Browse all FDA device recalls (products)