FDA Device recall Z-0230-2020
Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Produc…
- 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 PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Produc… 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-0230-2020 |
| 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 PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, 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: M00326420 Lot Numbers/UDI: 0000000676/ (01)04546540688774(17)201031(10)0000000676; 0000000984/ (01)04546540688…UPN: M00326420 Lot Numbers/UDI: 0000000676/ (01)04546540688774(17)201031(10)0000000676; 0000000984/ (01)04546540688774(17)201031(10)0000000984; 0000001019/ (01)04546540688774(17)201031(10)0000001019; 0000001281/ (01)04546540688774(17)201031(10)0000001281; 0000001292/ (01)04546540688774(17)201031(10)0000001292; 0000001498/ (01)04546540688774(17)201031(10)0000001498; 0000001644/ (01)04546540688774(17)201130(10)0000001644; 0000001915/ (01)04546540688774(17)201130(10)0000001915; 0000002059/ (01)04546540688774(17)201130(10)0000002059; 0000002232/ (01)04546540688774(17)201130(10)0000002232; 0000002769/ (01)04546540688774(17)201231(10)0000002769; 0000002977/ (01)04546540688774(17)201231(10)0000002977; 0000002978/ (01)04546540688774(17)201231(10)0000002978; 0000003121/ (01)04546540688774(17)201231(10)0000003121; 0000003122/ (01)04546540688774(17)201231(10)0000003122; 0000003466/ (01)04546540688774(17)210131(10)0000003466; 0000003773/ (01)04546540688774(17)210131(10)000000377 |
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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-0230-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.