Device recall

Z-1639-2013: - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot…

FDA device recall · Class II · Surgical Instrument Service And Savings, Inc.

Key facts

Recall number (Z-number) Z-1639-2013
Recall event 65205
Product - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429 Manual surgical instrument for general use
Product code KAM
Recalling firm Surgical Instrument Service And Savings, Inc.
Recall class Class II
Status Terminated
Termination date Jul 11, 2013
FEI number 3002299608

At a glance

  • None Linked 510(k)s
  • 10–99 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)