Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22,
Summary
The FDA issued a Class II for Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP C by Stryker Sustainability Solutions. Reason: Diagnostic electrophysiology (EP) catheters do not meet testing requirements..
Details
Source
Device Recall
External ID
Z-2268-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
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
Lot/Code Info: (UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402
Quantity Affected: 6 units
Reason for Recall
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
Distribution
International distribution to the country of Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-10
Company
Phoenix, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Stryker Sustainability Solutions has 46 FDA actions in our database, including 35 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Sustainability Solutions) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Sustainability Solutions have FDA actions?
Stryker Sustainability Solutions has 46 FDA actions in our database, including 35 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2268-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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