Deseret Epidural Catheter W/Toughy-Borst Adapter

• 2 recalls, same reason

  • Terminated Z-0467-06 FDA Unclassified (pre-2012) ·initiated 17 Nov 2005 ·on shared 510(k) K850505
  • Terminated Z-0468-06 FDA Unclassified (pre-2012) ·initiated 17 Nov 2005 ·on shared 510(k) K850505

  The catheter connector could not be sufficiently tightened to secure the catheter tubing.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K850505 ↗

FDA Product Code

BSO

Device Class

Class II

Regulation

21 CFR Part 868.5120

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Deseret Intravascular Catheter

  Class II

  FDA 510(k) K843033 Active Cleared 3 Dec 1984

• Deseret Neonatal Catheter Set

  Class II

  FDA 510(k) K834393 Active Cleared 13 Feb 1984

• Deseret Heparin Coated Flow Directed

  Class II

  FDA 510(k) K841317 Active Cleared 11 Jun 1984

• Orthopedic Tubular Stockinette

  Class I

  FDA 510(k) K760817 Active Cleared 20 Oct 1976

• Razor, Schick Disposable

  Not classified

  FDA 510(k) K760342 Active Cleared 11 Aug 1976

• Underpad, Disposable Polypropy. (Unilux)

  Class I

  FDA 510(k) K760164 Active Cleared 20 Jul 1976

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