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U.S. Department of Health and Human Services

Class 2 Device Recall Howell D.A.S.H. Extraction Balloon

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  Class 2 Device Recall Howell D.A.S.H. Extraction Balloon see related information
Date Initiated by Firm August 28, 2002
Date Posted October 24, 2003
Recall Status1 Terminated 3 on November 25, 2003
Recall Number Z-0068-04
Recall Event ID 27445
510(K)Number K953951  
Product Classification Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection - Product Code GCA
Product Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Code Information Lots 1602780, 160281, 1602782, 1602784, 1602785, 1602786, 1602788, 1602789, 1602790, 1602791, 1602792, 1602793, 1602794, 1602795, 1602796, 1602797, 1602798, 1602799, 1602800, 1602801, 1602802, 1607143, 1607144, 1610890, 1611901, 1613669, 1613670, 1614712, 1615429, 1615745, 1617031, 1617649, 1618498, 1620684, 1620928., 1621381, 1621496, 1621691, 1621692, 1622879, 16254321, 1626364, 1626669, 1627928, 1628134, 1629489, 1630384, 1630385, 1633042, 1633043, 1620783, 1623781, 1624348, 1625245, 1627107, 1629245, 1630813, 1634319, 1633787, 1634878, and 1635692.
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc
4900 Bethania Station Rd
& 5951 Grassy Creek Blvd.
Winston-Salem NC 27105
For Additional Information Contact Customer Service
800-245-4717
Manufacturer Reason
for Recall		 The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
FDA Determined
Cause 2		 Other
Action Field Representatives were notified via Fax or E-mail in August/September, 2002. After being notified about the recall, field representatives were responsible for notifying facilities about the market withdrawal and for furnishing instructions for returning products for credit.
Quantity in Commerce 2062 units
Distribution Nationwide; Argentina, Australia, Barbados, Bolivia, WI, Brazil, Canada, Costa Rica, Central Hong Kong, Colombia, Ecuador, El Salvador, England, Egypt, Guatemala, India, Indonesia, Ireland, Israel, Japan, Korea, Malaysia, Mexico, New Zealand, Pakistan, Philippines, Peoples Republic of China, Poland, Republic of Panama, Romania, Saudi Arabia, Singapore, Sri Lanka, Syria, Taiwan, Thailand, United Arab Emirates, Venezuela, Uruguay.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GCA and Original Applicant = WILSON-COOK MEDICAL, INC.
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