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U.S. Department of Health and Human Services

Class 2 Device Recall Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve

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  Class 2 Device Recall Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve see related information
Date Initiated by Firm December 16, 2010
Date Posted February 14, 2011
Recall Status1 Terminated 3 on August 08, 2012
Recall Number Z-1227-2011
Recall Event ID 57679
510(K)Number K003731  
Product Classification vascular interventional device - Product Code DYB
Product Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular interventional procedures. SafeSheath Sealing Adapter, Part No. FCL-094-03, Catalog No. SSSA-EW-09; SafeSheath Sealing Adapter, Part No. FCL-141-01, Catalog No. 369826; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07; Transvalvular Insertion Tool (TVI), Part #MIS-122-00, Catalog No. TVI-09; and CPS SafeSheath Sealing Adapter, Part No. XD-2754-00, Catalog No. 410195.
Code Information SafeSheath Sealing Adapter, Part No. FCL-094-03, Catalog No. SSSA-EW-09, Lot #S32071; SafeSheath Sealing Adapter, Part No. FCL-141-01, Catalog No. 369826, Lot #S32067; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07, Lot #S32830; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07, Lot #S33028; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07, Lot #S33050; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07, Lot #S33628; Transvalvular Insertion Tool (TVI), Part #MIS-122-00, Catalog No. TVI-09, Lot #S32206; and CPS SafeSheath Sealing Adapter, Part No. XD-2754-00, Catalog No. 410195, Lot No. S32546.
Recalling Firm/
Manufacturer		 Thomas Medical Products Inc
65 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information Contact Tim Stoudt
610-651-5054
Manufacturer Reason
for Recall		 Compromised sterility/weak or open seals.
FDA Determined
Cause 2		 Packaging process control
Action GE 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 Commerce 28,679 for all products
Distribution Distribution Nationwide USA and Germany.
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 = DYB and Original Applicant = THOMAS MEDICAL PRODUCTS, INC.
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