Trach Care Catheter

• 5 recalls, same reason

  • Terminated Z-1083-03 FDA Unclassified (pre-2012) ·initiated 13 Jun 2003
  • Terminated Z-1081-03 FDA Unclassified (pre-2012) ·initiated 13 Jun 2003
  • Terminated Z-1080-03 FDA Unclassified (pre-2012) ·initiated 13 Jun 2003
  • Terminated Z-1079-03 FDA Unclassified (pre-2012) ·initiated 13 Jun 2003
  • Terminated Z-1082-03 FDA Unclassified (pre-2012) ·initiated 13 Jun 2003

  Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.

510(k) Number

K872621 ↗

FDA Product Code

BSY

Device Class

Class I

Regulation

21 CFR Part 868.6810

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Safety Shield Suction Catheter

  Class I

  FDA 510(k) K873810 Active Cleared 11 Dec 1987

• Safety Shield Kit

  Class II

  FDA 510(k) K873731 Active Cleared 15 Jan 1988

• Reusable Bronchial Biopsy Forceps

  Class II

  FDA 510(k) K022398 Active Cleared 11 Oct 2002

• Trach Care Start Kit

  Class I

  FDA 510(k) K873732 Active Cleared 13 Oct 1987

• 72 Hour Use Trach Care with Microban

  Class II

  FDA 510(k) K974630 Active Cleared 11 Mar 1998

• Easi-Lav Pediatric / Adult Gastric Lavage Kit

  Class II

  FDA 510(k) K951533 Active Cleared 5 Jul 1995

See all devices from Ballard Medical Products →