FDA Device recall Z-0229-2020
Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: pr…
- FDA Device
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: pr… by Stryker Neurovascular, citing the product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0229-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-08 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker Neurovascular |
| Distribution | US |
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.
Reason
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.
Identifiers
| code_info | UPN: M00326410 Lot Numbers/UDI:0000000564/ (01)04546540688767(17)201031(10) 0000000564; 0000000565/ (01)04546540688…UPN: M00326410 Lot Numbers/UDI:0000000564/ (01)04546540688767(17)201031(10) 0000000564; 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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0229-2020%22
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