Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.
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 source text identifies the issue as a typographical error in labeling without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Stryker Neurovascular is recalling 21,971 units of Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating (UPN Product No. M00326410, REF 2641). The recall was initiated because the product labels (pouch and carton) contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct, and the correct millimeter value is 0.36mm. The 0.036mm value represents a typographical error.
The affected products were distributed worldwide, including nationwide in the United States and in numerous countries across Europe, Asia, the Americas, and the Middle East. The recall covers specific lot numbers and UDI codes listed in the official FDA record Z-0229-2020.
Consumers and healthcare providers should check their inventory for the affected lot numbers and UDI codes. If the product is found, it should be removed from use and returned to Stryker Neurovascular or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Guidewire
- Hazard
- Affected units
- 21,971
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 (20)
- 0000000565/ (01)04546540688767(17)201031(10)0000000565
- 0000000566/(01)04546540688767(17)201031(10)0000000566
- 0000000673/ (01)04546540688767(17)201031(10)0000000673
- 0000000674/ (01)04546540688767(17)201031(10)0000000674
- 0000000675/ (01)04546540688767(17)201031(10)0000000675
- 0000000983/ (01)04546540688767(17)201031(10)0000000983
- 0000000982/ (01)04546540688767(17)201031(10)0000000982
- 0000001016/ (01)04546540688767(17)201031(10)0000001016
- 0000001017/ (01)04546540688767(17)201031(10)0000001017
- 0000001018/ (01)04546540688767(17)201031(10)0000001018
- 0000001280/ (01)04546540688767(17)201031(10)0000001280
- 0000001279/ (01)04546540688767(17)201031(10)0000001279
- 0000001278/ (01)04546540688767(17)201031(10)0000001278
- 0000001289/ (01)04546540688767(17)201031(10)0000001289
- 0000001290/ (01)04546540688767(17)201031(10)0000001290
- 0000001291/ (01)04546540688767(17)201031(10)0000001291
- 0000001495/ (01)04546540688767(17)201031(10)0000001495
- 0000001497/ (01)04546540688767(17)201031(10)0000001497
- 0000001496/ (01)04546540688767(17)201031(10)0000001496
- 0000001640/ (01)04546540688767(17)201130(10)0000001640
Distribution
Part of a larger recall action
This product is one of 8 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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