Stryker Neurovascular Recalls Stroke Fast Packs Due to Labeling Mismatch
Stryker Neurovascular is recalling 48 Stroke Fast Packs because the pre-printed carton sleeve contents did not match the physical items inside.
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 the hazard is a labeling mismatch (minor labeling error) without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Stryker Neurovascular is recalling 48 units of Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001 ST 150. The recall is limited to specific lot numbers: QXC10107745, QXC10107814, and QXC10110247.
The recall was initiated because 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. This discrepancy could lead to confusion regarding the specific components included in the medical device kit.
The affected products were distributed nationwide. Healthcare providers and facilities should check their inventory for the specific lot numbers listed above. If these products are found, they should be removed from use and returned to Stryker Neurovascular or the authorized distributor.
The recalled product
- Product
- Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001 ST 150
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 48
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 (3)
- Lot Numbers: QXC10107745
- QXC10107814
- QXC10110247
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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