Stryker Neurovascular Recalls Stroke Fast Packs Due to Labeling Mismatch
Stryker Neurovascular is recalling 43 Stroke Fast Packs because the carton sleeve labels did not match the physical contents inside the packs.
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, but the source text describes a labeling mismatch without reporting any injuries, illnesses, or specific clinical harm, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Stryker Neurovascular is recalling 43 Stroke Fast Packs (Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001) due to a labeling discrepancy. The company identified that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back did not match the physical contents of the pack.
The affected products are distributed nationwide. The specific lot numbers involved in this recall are QPC20107530, QPC20107745, QPC20107814, and QPC20110247.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected packs. Users should contact Stryker Neurovascular for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 43
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 (4)
- Lot Numbers: QPC20107530
- QPC20107745
- QPC20107814
- QPC20110247
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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