Recall Z-0055-2013 ยท DQO Catheter, Intravascular, Diagnostic
ICU Medical, Inc.
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
| Date | Oct 11, 2012 (initiated Sep 28, 2012) |
| Status | Terminated |
| Reason | ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set. |
| Root cause | Mixed-up of materials/components |
| Action | ICU Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated September 28, 2012 to its customer. The letter identified the product, problem, and actions to be taken by the customer. The customer has been instructed to inspect their inventory for the specific lot numbers, examine for the presence of a metal cannula, and certify destruction of any affected devices. The customer letter included a Verification Form to be completed and returned. Contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail |
| Quantity | 60 |
| Distribution | Nationwide distribution: Virginia only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914299 | CARDIAC CATHERIZATION KIT Abbott Laboratories, Jun 3, 1992 |