Recall Z-0963-2017— 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 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 to the appropriate equipment. The cables either interface an ablation catheter with the appropriate external radiofrequency generator or, serve as an extension cable between an ablation 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 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 to the appropriate equipment. The cables either interface an ablation catheter with the appropriate external radiofrequency generator or, serve as an extension cable between an ablation 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.