ZOLL Circulation, Inc. Recall 88671
Description: ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213
ZOLL Circulation, Inc. Recall 88671 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0045-2022 |
Event ID | 88671 |
Event Description | ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213 |
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 | 6,395 units |
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 |
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