Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabiliti
Summary
The FDA issued a Class II for Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit by ZOLL Circulation, Inc.. Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing.
Details
Source
Device Recall
External ID
Z-0047-2022
Action Date
2021-10-13
Status
Terminated
Category
device
Product 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
Lot/Code Info: All Lots
Quantity Affected: 33,066 units
Reason for Recall
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-06
Company
San Jose, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ZOLL Circulation, Inc. has 35 FDA actions in our database, including 30 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ZOLL Circulation, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ZOLL Circulation, Inc. have FDA actions?
ZOLL Circulation, Inc. has 35 FDA actions in our database, including 30 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0047-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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