Medtronic Preimplantation Test Kit Recalled for Incorrect Expiration Dates
Medtronic Neurosurgery is recalling Preimplantation Test Kits because the outer carton expiration dates are later than the dates on the individual sterile components.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a documentation and packaging labeling issue where the outer carton date is later than the component dates, fitting the rubric for cosmetic defects or documentation issues.
Plain-English summary
Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit, Catalog No. 21047. The recall involves 915 units that were distributed nationwide in the United States. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves to verify that the valve conforms to labeled product specifications.
The recall was initiated because the expiration dates printed on the outer carton are incorrect. Specifically, the date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components contained within the kit.
Healthcare providers and facilities that have received these kits should stop using them and contact Medtronic Neurosurgery for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.
- Manufacturer
- Medtronic Neurosurgery
- Category
- Medical Device — Neurosurgery
- Hazard
- Affected units
- 915
Distribution
Distributed nationwide across the United States.
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