MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron F
FDA device recall Z-2053-2019 · posted 2019-07-23 · Terminated
Recall details
- Recalling firm
- Zevex Incorporated (dba MOOG Medical Devices Group)
- Reason for recall
- Administration sets leaked at the filter.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 569/20-set caess
- Distribution
- Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution.
- Date initiated
- 2019-02-27
- Date posted
- 2019-07-23
- Date terminated
- 2021-04-28
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CUE AMBULATORY VOLUMETRIC INFUSION PUMP (K981816) | Becton Dickinson Curlin, LLC | 1998-12-04 |