| Class 2 Device Recall Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DYB
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