Device recall

Z-1444-2013: I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T…

FDA device recall · Class II · I-Flow LLC

Key facts

Recall number (Z-number) Z-1444-2013
Recall event 64826
Product I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
Product code BSO
Recalling firm I-Flow LLC
Recall class Class II
Status Terminated
Termination date Jun 25, 2013
510(k) numbers K904440
FEI number 3011270181

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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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