Recall Z-0661-2010 ยท DYB Introducer, Catheter
Thomas Medical Products Inc
Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and catheters. The product is shipped 5 per carton. Product is distributed by Pressure Products. Catalog numbers: CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09, CSG-WORLEY-Bcor-1-09, CSG/WORLE
| Date | Feb 2, 2010 (initiated Dec 17, 2009) |
| Status | Terminated |
| Reason | Radiopaque sheath tip may fracture |
| Root cause | Component design/selection |
| Action | GE Healthcare Thomas Medical Products firm issued an Urgent Medical Device Correction email on 12/23/09 to the distributor to discontinue distribution and return any affected products. The distributor was instructed to conduct a sub recall regarding the issue. Press issued 1/29/2010. |
| Quantity | 60,982 units |
| Distribution | Nationwide. |
| 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 |