Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, s
FDA device recall Z-2268-2024 · posted 2024-07-03 · Open, Classified
Recall details
- Recalling firm
- Stryker Sustainability Solutions
- Reason for recall
- Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NLH
- Quantity affected
- 6 units
- Distribution
- International distribution to the country of Japan.
- Date initiated
- 2024-05-10
- Date posted
- 2024-07-03
- Location
- Phoenix, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER (K112292) | Stryker Sustainability Solutions | 2011-10-21 |