Recall Z-0964-2017— Stryker Sustainability Solutions
Class II · Terminated
Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2016-12-06, terminated 2017-06-08. FDA's recall record names no specific 510(k) clearance for this event. 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 cables either interface an EP catheter with the appropriate external stimulation or recording equipment or, serve as an extension cable between an EP catheter and equipment out of immediate reach. Reason: A breach in the sterile packaging may have occurred resulting in potentially non-sterile product..
- Recalling firm
- Stryker Sustainability Solutions
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-06
- Terminated
- 2017-06-08
- Firm location
- Tempe, AZ, United States
Product description
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 cables either interface an EP catheter with the appropriate external stimulation or recording equipment or, serve as an extension cable between an EP catheter and equipment out of immediate reach
Reason for recall
A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.