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
Reported: July 10, 2024 Initiated: May 10, 2024 #Z-2268-2024
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.
Details
- Recalling Firm
- Stryker Sustainability Solutions
- Units Affected
- 6 units
- Distribution
- International distribution to the country of Japan.
- Location
- Phoenix, AZ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Stryker Sustainability Solutions. Units affected: 6 units.
Why was this product recalled? ▼
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2024. Severity: Moderate. Recall number: Z-2268-2024.
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