CLASS II Device recall · Reported 13 Oct 2021 · FDA Enforcement Report
Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat recalled
Zoll Circulation is recalling Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat, distributed nationwide in the US. The recall was initiated on 6 Aug 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0056-2022
- FDA event ID
- 88671
- Recalling firm
- Zoll Circulation, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2021
- FDA classified
- 6 Oct 2021
- Reported
- 13 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 6 Aug 2021 | Recall initiated by company | |
| 6 Oct 2021 | Classified by FDA | +61 days |
| 13 Oct 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiMontana
Questions about this recall
Why was it recalled?
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Which lots are affected?
All Lots
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
27 other products · FDA event 88671This product is part of a recall event; the main page for the event is Zoll, REF 8700-0793-40 (SL-2593AE) Solex 7, Intravascular Heat recalled.
More recalls from Zoll Circulation
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | AutoPulse NXT Resuscitation System AutoPulse NXT Platform recalled | Zoll Circulation | Device Malfunction | 18 states |
| Device | CLASS II | AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System recalled | Zoll Circulation | Device Malfunction | 47 states |
| Device | CLASS II | Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat recalled | Zoll Circulation | Packaging Defects | Nationwide |
| Device | CLASS II | Zoll REF: 8700-0783-01 (IC-4593) recalled by ZOLL Circulation | Zoll Circulation | Packaging Defects | Nationwide |
| Device | CLASS II | Zoll REF: 8700-0783-14 (IC-4593CO), Quattro Intravascular Heat recalled | Zoll Circulation | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |