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 Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
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Food and Drug Administration
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Suite 200N/HFM-47
Rockville, MD 20852-1448

