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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448