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U.S. Department of Health and Human Services

Medical Devices

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Bard RapidFire Multiple Band Ligator (Item No. 000608)

Class I Recall

The following information relates to FDA's decision to issue a Class I recall for this product. 

Date Recall Initiated
January 31, 2002
Bard RapidFire Multiple Band Ligator (Item No. 000608)
Used for binding or tying off veins, arteries or lymph vessels abnormally dilated and twisted. This product is intended for use by physicians during surgical procedures.
Recalling Firm:
Bard Endoscopic Technologies, Division of C.R. Bard, Inc.
129 Concord Road, Bldg #3
Billerica, MA 01821
Reason for Recall:
Inadequate chlorination of the ligature bands causing them to become tacky and not deploy properly during application.
Public Contact:
Ms. Beth Zis
Director of Regulatory Affairs
Phone: 978-663-8989
FDA District:
New England District
FDA Comment:
FDA considers there to be a risk of death since the band ligator may fail to deploy and prevent control of bleeding.