Recall record at a glance
| Official record | Z-1337-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Report date | May 22, 2019 |
| Recall initiation date | Apr 18, 2019 |
| Quantity | 1258 |
| Location | Ann Arbor, MI, United States |
Official product description
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
Why the product was recalled
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Distribution information
Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.
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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