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U.S. Department of Health and Human Services

Class 2 Device Recall SafeSheath Long, (TearAway Sheath Introducer Set with Integral Hemostasis Valve)

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 Class 2 Device Recall SafeSheath Long, (TearAway Sheath Introducer Set with Integral Hemostasis Valve)see related information
Date Initiated by FirmDecember 16, 2010
Date PostedFebruary 14, 2011
Recall Status1 Terminated 3 on August 08, 2012
Recall NumberZ-1226-2011
Recall Event ID 57679
510(K)NumberK934901 
Product Classification vascular interventional device - Product Code DYB
ProductThomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis Valve) for use during vascular interventional procedures. Part No. FCL-051-00, Catalog No. HLS2507MCN; and Part No. FCL-051-02, Catalog No. HLS2507MCN.
Code Information Part No. FCL-051-00, Catalog No. HLS2507MCN, Lot #S33309; and Part No. FCL-051-02, Catalog No. HLS2507MCN, Lot #S33308.
Recalling Firm/
Manufacturer		 Thomas Medical Products Inc
65 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information ContactTim Stoudt
610-651-5054
Manufacturer Reason
for Recall		Compromised sterility/weak or open seals.
FDA Determined
Cause 2		Packaging process control
ActionGE Healthcare Thomas medical products Recall notification dated 16 December 2010 (GEHC Ref # 35003) was sent by letter via UPS Next Day Air and/or USPS certified mail.
Quantity in Commerce28,679 for all products
DistributionDistribution Nationwide USA and Germany.
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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