Stryker Sustainability Solutions: Device Recall

Recall Details

Recall Number

Z-2268-2024

Classification

Class II

Product Type

Device

Recalling Firm

Stryker Sustainability Solutions

Status

Ongoing

Date Initiated

05/10/2024

Location

Phoenix, AZ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

6 units

Reason for Recall

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

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

Distribution Pattern

International distribution to the country of Japan.

Other Recalls by Stryker Sustainability Solutions

• Class II: Risk 09/24/2025
  Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
• Class II: Risk 07/02/2024
  Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.
• Class II: Risk 05/31/2024
  Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.

View all recalls by Stryker Sustainability Solutions →