Medical Device Recall
Ranger High Flow Blood / Fluid Warming Disposable Sets
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.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.