Stryker GDC 360 Coils Recalled for Expiration Date Violations
Stryker Neurovascular is recalling GDC 360 coils, Target coils, and Gateway PTA Balloon Catheters shipped to US customers beyond their expiration dates.
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: This is an FDA Class II recall involving a documentation and compliance issue (shipping beyond expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Neurovascular is recalling specific units of GDC 360 coils, Target coils, and Gateway PTA Balloon Catheters. The recall is due to the fact that these medical devices were shipped to US customers after they had passed their expiration dates.
The affected products include the GDC-10 360 10mm x 30cm SR model (Model M0033461030SRO, Lot number 13239506, Exp. Jan 2013). These devices are intended for the embolization of intracranial aneurysms that are considered very high risk for traditional operative techniques or inoperable. The distribution pattern for the recalled units includes US customers in the states of Virginia, New Hampshire, Ohio, and Texas.
Healthcare providers and patients who have received these specific units should contact Stryker Neurovascular for instructions on how to return or replace the devices. Using medical devices beyond their expiration date may compromise their safety and effectiveness, although the source text does not report specific injuries or illnesses associated with this recall.
The recalled product
- Product
- GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a)
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Affected units
- 1
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)
- Model M0033461030SRO
- Lot number: 13239506
- Exp. Jan 2013.
Distribution
Part of a larger recall action
This product is one of 5 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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