Thomas 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.
FDA Recall Z-1226-2011 · Posted 2011-02-14
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Recalling FirmThomas Medical Products Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2010-12-16
Date Terminated2012-08-08
Product Quantity28,679 for all products
Reason for Recall
Compromised sterility/weak or open seals.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Distribution Nationwide USA and Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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