Recall Z-2053-2019 ยท FRN Pump, Infusion
Zevex Incorporated (dba MOOG Medical Devices Group)
MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set to be used with the Moog Curlin Infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
| Date | Jul 23, 2019 (initiated Feb 27, 2019) |
| Status | Terminated |
| Reason | Administration sets leaked at the filter. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued a letter dated 2/27/2019 via regular mail on 2/272019 to their direct accounts describing the issue, risk to health, and the necessary actions to be taken. |
| Quantity | 569/20-set caess |
| Distribution | Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution. |
| 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 |