Z-2268-2024 Class II Ongoing
FDA device recall Z-2268-2024 was initiated by Stryker Sustainability Solutions on May 10, 2024 and is designated Class II. Reason for recall: Diagnostic electrophysiology (EP) catheters do not meet testing requirements. The recall status is ongoing. Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 10, 2024
- Initiation Date
- May 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
Reason for Recall
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
Distribution Pattern
International distribution to the country of Japan.
Code Information
(UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2268-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026