Recall record at a glance
| Official record | Z-2054-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zevex Incorporated (dba MOOG Medical Devices Group) |
| Report date | Jul 31, 2019 |
| Recall initiation date | Feb 27, 2019 |
| Quantity | 756/20-set cases |
| Location | Salt Lake City, UT, United States |
Official product description
MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.
Why the product was recalled
Administration sets leaked at the filter.
Distribution information
Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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