Recall record at a glance
| Official record | Z-1363-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Natus Medical Inc. |
| Report date | Apr 20, 2016 |
| Recall initiation date | Jan 8, 2016 |
| Quantity | 75 units (65 units in the US and 10 units in Pakistan) updated in final status report 36 customers with 96 units. |
| Location | Seattle, WA, United States |
Official product description
Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
Why the product was recalled
NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator.
Distribution information
Distribution US nationwide and Pakistan.
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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