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
This recall is currently active, issued July 3, 2024. It was issued by Stryker Sustainability Solutions.
- Company
- Stryker Sustainability Solutions
- Recall Initiated
- May 10, 2024
- Posted
- July 3, 2024
- Recall Number
- Z-2268-2024
- Quantity
- 6 units
- Firm Location
- Phoenix, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
Distribution
International distribution to the country of Japan.
Lot / Code Info
(UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402
Root Cause
Process control
Action Taken
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: SSSPFA@stryker.com 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.