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.
FDA Recall Z-2053-2019 · Posted 2019-07-23
Recalling FirmZevex Incorporated (dba MOOG Medical Devices Group)
Recall StatusTerminated
Product CodeFRN
Date Initiated2019-02-27
Date Terminated2021-04-28
Product Quantity569/20-set caess
Reason for Recall
Administration sets leaked at the filter.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.