• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Medical Device Recall - Ranger High Flow Blood / Fluid Warming Disposable Sets-Biotest Laboratories, Inc. / Arizant, Inc.

DATE RECALL INITIATED:

April 26, 2006

PRODUCT / LOT NUMBER

Ranger High Flow Blood / Fluid Warming Disposable Sets
Lots H2057 through H2182
Part Numbers: 24350, 24355, 24365, 24370

RECALLING FIRM:

Arizant, Inc.
Eden Prairie, Minnesota

MANUFACTURER:

Biotest Laboratories, Inc.
Minneapolis, Minnesota

REASON:

High-flow disposable sets for the Ranger blood/fluid warming system may have been assembled with an inverted bubble trap. An inverted bubble trap on a Ranger high flow system may allow air to pass through the bubble trap and bypass the trap’s auto-venting mechanism, potentially permitting air to reach the patient. Consignees have been asked to contact the recalling firm to arrange for replacement product.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002