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
FDA Recall Z-2268-2024 · Posted 2024-07-03
Recalling FirmStryker Sustainability Solutions
Recall StatusOpen, Classified
Product CodeNLH
Date Initiated2024-05-10
Product Quantity6 units
Reason for Recall
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
Firm Action
On June 11, 2024, Stryker Sustainability Solutions issued a Medical Device Recall notification to affected consignees. Stryker ask consignees to take the following action:
1. Please complete the Urgent Medical Device Recall Business Reply Form Attachment A (page 3) as an acknowledgement of this notification. Please return this completed form through one of the following methods:
"Email: [email protected] or To your Stryker s Sustainability Solutions Sales Representative or via: Fax: 480-763-5345 5.
2.Maintain awareness of this communication internally. Response is required.
Root Cause
Process control
Distribution Pattern
International distribution to the country of Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.