Recall Z-0168-2012 ยท DYB Introducer, Catheter
Thomas Medical Products Inc
SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Series, and Situs LDS2 Lead Delivery System - Catalog numbers: CSG/WORLEY/BCor-1-09; CSG/WORLEY/BCor-2-09; CSG/WROLEY/L/BCor-1-09; CSG/Worley/R-1-09; CSGWORBC10M; CSGWORBC29M; CSGWORLBC19M; LVI/66-5.5-CR; LVI/66-5.5-RE; LVI/75-5-62-07-HO; LVI/75-5-62-07-HS; LVI/75-5-62-07-MP; LVI/7
| Date | Jan 11, 2012 (initiated Oct 7, 2011) |
| Status | Terminated |
| Reason | Radiopaque (RO)/soft tip of the braided core component in the CSG kits may detach from the braided core tube. |
| Root cause | Nonconforming Material/Component |
| Action | The firm,GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 7, 2011, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately segregate all affected product in a manner that ensures it will not be used; return any product with reference to the return authorization (RA) number or contact customer service representative to facilitate return of product; if any affected product has been forwarded to another facility, contact that facility to arrange return, and complete and return the attached pro |
| Quantity | 33,134 |
| Distribution | Nationwide distribution: CA only. |
| 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 |