Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Reported: November 21, 2018 Initiated: August 23, 2018 #Z-0467-2019
Product Description
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Reason for Recall
Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
Details
- Recalling Firm
- Stryker Sustainability Solutions
- Units Affected
- 2
- Distribution
- US: KS OUS: None
- Location
- Tempe, AZ
Frequently Asked Questions
What product was recalled? ▼
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.. Recalled by Stryker Sustainability Solutions. Units affected: 2.
Why was this product recalled? ▼
Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 21, 2018. Severity: Moderate. Recall number: Z-0467-2019.
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