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ZOLL Circulation, Inc. Recall 88671

Description: Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)

ZOLL Circulation, Inc. Recall 88671 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0061-2022
Event ID88671
Event DescriptionZoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
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.
Quantity334 bundles
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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