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Talon Infusion Set, Model Ip Xxxx

by ICU Medical, Inc.

510(k) K033290

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033290 Date12 Apr 2004ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0592-2012 FDA Unclassified (pre-2012) initiated 1 Mar 2011

    The recall was initiated because ICU Medical Inc. has become aware of the market recall of the Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names. The Triad alcohol prep pads have the potential contamination of the bacteria, Bacillus cereus. The Triad Group alcohol prep pads have been copackaged

    • Terminated Z-0593-2012 FDA Unclassified (pre-2012) initiated 1 Mar 2011

    The recall was initiated because ICU Medical Inc. has become aware of the market recall of the Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names. The Triad alcohol prep pads have the potential contamination of the bacteria, Bacillus cereus. The Triad Group alcohol prep pads have been copackaged a

    • Terminated Z-1166-2007 FDA Unclassified (pre-2012) initiated 26 Sep 2006

    The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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