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ZOLL Circulation, Inc. Recall 88671

Description: Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251

ZOLL Circulation, Inc. Recall 88671 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0047-2022
Event ID88671
Event DescriptionZoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251
Product TypeDevices
DistributionWorldwide 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.
Quantity33,066 units
Recall ReasonLabeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Device Classification20211013
Device Code InfoAll Lots
Center Classification Date20211006
Recall Initiation Date20210806
Recalling FirmZOLL Circulation, Inc.
Initial Notification Letter
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