ZOLL Circulation, Inc. Recall 88671
Description: Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107
ZOLL Circulation, Inc. Recall 88671 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0057-2022 |
| Event ID | 88671 |
| Event Description | Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, TAIWAN, THAILAND. |
| Quantity | 58 kits |
| Recall Reason | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Device Classification | 20211013 |
| Device Code Info | All Lots |
| Center Classification Date | 20211006 |
| Recall Initiation Date | 20210806 |
| Recalling Firm | ZOLL Circulation, Inc. |
| Initial Notification | Letter |
| Similar To |