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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
Product:
 Bard RapidFire Multiple Band Ligator (Item No. 000608)
Use:
 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.

 

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