Recall Z-2179-2010 ยท DYB Introducer, Catheter
St. Jude Medical Cardiovascular Division
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094.
| Date | Aug 12, 2010 (initiated Jun 28, 2010) |
| Status | Terminated |
| Reason | Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief. |
| Root cause | Process design |
| Action | Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory. Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks. A St. Jude Medical s |
| Quantity | 90 OUS |
| Distribution | Worldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia. |
| FDA record | Open on fda.gov |