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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

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-0057-2022
Event ID88671
Event DescriptionZoll, 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 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.
Quantity58 kits
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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