Stryker Neurovascular Recalls Stroke Intervention Kits Due to Label Mismatch
Stryker Neurovascular is recalling 2 units of Stroke Fast Packs and Trevo Procedure Packs because the carton sleeve labels did not match the physical contents inside.
What this means for you
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 involves a labeling error where the sleeve does not match the contents. This is a significant risk of using the wrong device, but no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Neurovascular is recalling 2 units of Stroke Fast Packs and Trevo Procedure Packs. The affected products include the Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER, 150 cm, 6 cm; and AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, with UPN M0033PK62523002.
The recall was initiated because the products were manufactured using a carton sleeve where the label contents did not match the physical contents within the pack. This discrepancy could lead to the use of incorrect medical devices during stroke interventions.
The affected lots are QXC10200044 and QXC10200043, both with an expiration date of 28-Aug-18. The products were distributed internationally to Germany, Slovakia, and Israel. Healthcare providers and patients should verify the lot numbers and expiration dates of their devices and contact Stryker Neurovascular for further instructions.
The recalled product
- Product
- Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 2
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: QXC10200044
- exp. date 28-Aug-18
- QXC10200043
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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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