Bair Hugger Blood/Fluid Warmer

• • Ongoing Z-2483-2025 FDA Class I ·initiated 10 Apr 2025

  Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.

• 2 recalls, same reason

  • Terminated Z-1183-2007 FDA Unclassified (pre-2012) ·initiated 26 Jun 2007 ·via K973741, on the same 510(k)
  • Terminated Z-1184-2007 FDA Unclassified (pre-2012) ·initiated 26 Jun 2007 ·via K973741, on the same 510(k)

  Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K973741 ↗

FDA Product Code

BSB

Device Class

Class II

Regulation

21 CFR Part 864.9205

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Bair Hugger Model 630 Cardiac Blanket

  Class II

  FDA 510(k) K964673 Active Cleared 26 Jun 1997

• System, Thermal Regulating 74-Dwj

  Class II

  FDA 510(k) K960167 Active Cleared 17 Jun 1996

• Bair Hugger Cub Blanket- Short Model 536

  Class II

  FDA 510(k) K920432 Active Cleared 18 Jun 1992

• Augustine Guide Kit

  Class I

  FDA 510(k) K921166 Active Cleared 23 Apr 1992

• Augustine Stylet

  Class I

  FDA 510(k) K910659 Active Cleared 17 May 1991

• Bair Hugger Model 600 Unit, Blankets

  Class II

  FDA 510(k) K950416 Active Cleared 29 Aug 1995

See all devices from Augustine Medical, Inc. →