Stryker Stroke Fast Pack Recall Due to Mismatched Carton Sleeve Labeling
Stryker Neurovascular is recalling 139 Stroke Fast Packs because the pre-printed contents on the carton sleeve did not match the physical contents of the pack.
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 mismatch where the carton sleeve does not match the physical contents. This fits the rubric for moderate severity, as it is a labeling error without reported injuries or deaths.
Plain-English summary
Stryker Neurovascular is recalling 139 Stroke Fast Packs (Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US) 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 identified by the following lot numbers: QPC40107530, QPC40107745, QPC40107814, and QPC40110247. The recall is classified as Class II by the FDA. The source text does not specify the geographic distribution of the affected units or provide instructions for consumers on how to return the product.
The recalled product
- Product
- Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 139
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: QPC40107530
- QPC40107745
- QPC40107814
- QPC40110247
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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