Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2022-06-23 | Z-1530-2022 | Class II | Open, Classified | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.Distribution: Product distributed to Family Dollar retail stores in US nationwide. | 2877 total | clearance family |
Regulatory clearances
- 510(k)K160399Substantially equivalent (SESE) · 2016-07-25clearance family
Predicate lineage
K941258
Cited as predicate by: K163107
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
None in the loaded window.
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