Recall Z-2268-2024— Stryker Sustainability Solutions

Name: FDA recall Z-2268-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-10

Class II · Ongoing

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2024-05-10. It names one FDA 510(k) clearance: K112292. Product: 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. Reason: Diagnostic electrophysiology (EP) catheters do not meet testing requirements..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Ongoing
Initiated: 2024-05-10
Firm location: Phoenix, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K112292 — REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETERStryker Sustainability Solutions·cleared 2011-10-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

Diagnostic electrophysiology (EP) catheters do not meet testing requirements.

Data sourced from openFDA. This site is unofficial and independent of the FDA.