Recall Z-1226-2011 ยท DYB Introducer, Catheter
Thomas Medical Products Inc
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.
| 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
| K934901 | TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE Thomas Medical Products, Inc., Jan 21, 1994 |