The Recall Desk

FDA (Devices) recall action 75941

Stryker Sustainability Solutions recalled 2 products on 2017-01-18

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-01-18
Critical
0
Units
—

Why these products were recalled

A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2017-01-18

    Stryker Recalls Reprocessed Electrophysiology Catheter Cables Due to Sterility Breach

    Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheter cables because a breach in sterile packaging may have occurred, potentially rendering the product non-sterile.

    Product
    Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The…
    Category
    Distribution
    35 states
  • HighFDA (Devices)··2017-01-18

    Stryker Recalls Reprocessed Ablation Catheter Cables Due to Sterility Concerns

    Stryker is recalling reprocessed ablation catheter cables because a breach in sterile packaging may have resulted in non-sterile product.

    Product
    Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a multi-pin connector on the proximal end which connects…
    Category
    Distribution
    35 states