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.
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-1227-2011
- 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
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.
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.