Recall Z-0650-2013 ยท DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
California Medical Laboratories Inc
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
| Date | Jan 7, 2013 (initiated Nov 2, 2012) |
| Status | Terminated |
| Reason | California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity. |
| Root cause | Nonconforming Material/Component |
| Action | CalMed sent an Urgent Field Safety Notice dated November 2, 2012, to all affected customers by certified mail and additionally followed up via electronic mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Sorin Group USA's Customers Service Department at +1-800-650-2623 to return any unused product and order replacements. Customers were also asked to communicate the important safety information to all potential users within their organization or any other organization where the affected product may have been |
| Quantity | S112468N=1000 units, S120196N=1400 units, & S120197N=1200 units |
| Distribution | Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982891 | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS California Medical Laboratories, Inc., Sep 30, 1998 |