Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates
Stryker Neurovascular is recalling Excelsior SL-10 microcatheters because they were shipped with use-by dates exceeding available shelf-life data.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding shelf-life data without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Neurovascular is recalling Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM microcatheters (Catalog Number: M0031441920). The recall involves products that were shipped with "use by" dates that exceed currently available shelf-life data. All affected products remain within the earliest expiration date of April 2015.
The products are manufactured by Stryker Neurovascular in Cork, Ireland, and distributed by Stryker Neurovascular in Fremont, CA. The recall covers worldwide distribution, including the United States and international markets in Europe, Asia, Australia, Canada, and South America.
These microcatheters are intended to assist in the delivery of diagnostic and therapeutic agents into the peripheral, coronary, and neurovasculature. The recall is a precautionary measure to ensure that the labeled expiration dates align with the currently available shelf-life data.
The recalled product
- Product
- Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM; Catalog Number: M0031441920; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular…
- Manufacturer
- Stryker Neurovascular
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 17048727
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Stryker Neurovascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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