Recall Z-1868-2011 ยท FRN Pump, Infusion
Zevex International, Inc.
Curlin 6000 IOD Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
| Date | Apr 5, 2011 (initiated Feb 28, 2011) |
| Status | Terminated |
| Reason | Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed. |
| Root cause | Software design |
| Action | The firm, MOOG, sent an "URGENT DEVICE RECALL NOTIFICATION" letter dated February 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: 1) Identify the affected Pumps: a) If they have an affected pump, fill out and return the enclosed Business Reply Card within five (5) working days. b) If their pump is not affected by this recall, the pump can be used for its intended purposes. 2) Removal of affected Product: a) remove affected products from service and use non-affected pump b) If you do not have an alt |
| Quantity | 3,407 units |
| Distribution | Worldwide distribution: USA and countries including: Australia, Canada, Costa Rica, Croatia, Dubai, France, Germany, Ireland, Italy, Japan, Jordan, Kuwait, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Taiwan, Turkey, UAE, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981816 | CUE AMBULATORY VOLUMETRIC INFUSION PUMP Becton Dickinson Curlin, LLC, Dec 4, 1998 |