Recall Z-0963-2017 ยท NLH Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions
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 g
| Date | Jan 7, 2017 (initiated Dec 6, 2016) |
| Status | Terminated |
| Reason | A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. |
| Root cause | Under Investigation by firm |
| Action | Customer notification letters were sent 12/06/16. Customers were asked to use the criteria of Item Number and Expiration Date to determine if any affected product remains in inventory. Use of the products from the affected item number and expiration date should be discontinued. Customers are instructed to follow the web link below to complete the Recall Effectiveness Check Form and indicate if any devices with the affected item number and expiration date listed above remain in inventory. ONLINE form must be completed even if no affected product is found. Use Stryker Sustainability Soluti |
| Distribution | U.S. distribution to the following: MI, TX, TN, IN, AL, FL, PA, AK, WI, MT, SC, CO, CA, NH, NC, NJ, DE, AZ, MN, MS, GA, DC, IA, NY, NM, KS, OH, OK, SD, OR, NV, VA, MD, WA, CT Foreign distribution to the following: CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.