Recall Z-1227-2011 ยท DYB Introducer, Catheter
Thomas Medical Products Inc
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), Pa
| Date | Feb 14, 2011 (initiated Dec 16, 2010) |
| Status | Terminated |
| Reason | Compromised sterility/weak or open seals. |
| Root cause | 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 | 28,679 for all products |
| Distribution | Distribution Nationwide USA and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003731 | SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE Thomas Medical Products, Inc., Apr 10, 2001 |