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.
This recall has been terminated (originally issued February 14, 2011).
- Company
- Thomas Medical Products Inc
- Recall Initiated
- December 16, 2010
- Posted
- February 14, 2011
- Terminated
- August 8, 2012
- Recall Number
- Z-1226-2011
- Quantity
- 28,679 for all products
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Compromised sterility/weak or open seals.
Distribution
Distribution Nationwide USA and Germany.
Lot / Code Info
Part No. FCL-051-00, Catalog No. HLS2507MCN, Lot #S33309; and Part No. FCL-051-02, Catalog No. HLS2507MCN, Lot #S33308.
Root Cause
Packaging process control
Action Taken
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.
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