Stryker Neurovascular Recalls Synchro2 Guidewires Due to 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

• mis-labeling

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.

Distribution

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