Recall Z-1228-2011 ยท DQY Catheter, Percutaneous
Thomas Medical Products Inc
Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve, Acuity Universal Cutter, and Contamination Sleeve for use during vascular interventional procedures. Contamination Sleeve part no. CON-006-02; Acuity Bleedback Control Valve part no. CSP-001-00; Acuity Rotating Hemostasis Valve part no. CSP-002-01; Acuity Universal Cutter part no. CSP-003-00; Acuity Univer
| 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 |