Recall Z-0592-2012 ยท FPA Set, Administration, Intravascular
ICU Medical, Inc.
Orbit and Orbit Micro Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our devices within an outer container. Removal of the wipes will not compromise the sterile barrier of our device and can easily be identified and replaced.
| Date | Jan 11, 2012 (initiated Mar 1, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because ICU Medical Inc. has become aware of the market recall of the Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names. The Triad alcohol prep pads have the potential contamination of the bacteria, Bacillus cereus. The Triad Group alcohol prep pads have been copackaged |
| Root cause | Pending |
| Action | The firm, ICU Medical, Inc., sent an "IMPORTANT-Important Information About Triad Group's Alcohol Prep Pads" letter dated March 2, 2011 (via email) to their distributors. Hard copy notices were shipped (via next day express delivery with receipt confirmation) to all their customers. The Important letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were informed that the Orbit and Orbit Micro subcutaneous infusion sets as well as the IV start kits are not contaminated and may continue to be used according to the directions for use. |
| Quantity | 376,290 units |
| Distribution | Worldwide distribution: USA (Nationwide) and countries of: Austria, Belgium, Chile, Cyprus, CZ, France, Germany, Great Britain, Greece, Israel, Italy, Lithuania, Netherland, Poland, Russia, Saudi Arabia, Sweden, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033290 | TALON INFUSION SET, MODEL IP XXXX Icu Medical, Inc., Apr 12, 2004 |