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U.S. Department of Health and Human Services

Class 3 Device Recall Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport.

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 Class 3 Device Recall Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport.see related information
Date Initiated by FirmNovember 07, 2005
Date PostedDecember 17, 2005
Recall Status1 Terminated 3 on June 14, 2006
Recall NumberZ-0297-06
Recall Event ID 34028
510(K)NumberK934901 
Product Classification Introducer, Catheter - Product Code DYB
ProductBard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case.
Code Information Catalog number 808950, Lot number S16143
Recalling Firm/
Manufacturer		 Thomas Medical Products Inc
65 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information ContactTim Stoudt
610-296-3000 Ext. 228
Manufacturer Reason
for Recall		mislabeled as 9.5F actually contains 10.5F
FDA Determined
Cause 2		Other
ActionThe recalling firm issued letters to their direct accounts via fax on 11/7/05. Letters to the hospital accounts were mailed via UPS overnight on 11/14/05.
Quantity in Commerce445 kits
DistributionThe products were shipped to one distributor in CA and the label holder in MA. The products were further distributed to hospitals in CA, CO, IL, KY, MO, MS, NC, NE, NY, OH, PA, SC, and TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DYB
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