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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88671

28 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 06, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ZOLL Circulation, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

28 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 28

Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237

Z-0039-2022
Recall number
Z-0039-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
17,869 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 2 of 28

Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3

Z-0040-2022
Recall number
Z-0040-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
1,253 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 3 of 28

ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190

Z-0041-2022
Recall number
Z-0041-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
4,812 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 4 of 28

ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:

Z-0042-2022
Recall number
Z-0042-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
5,524 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 5 of 28

ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312

Z-0043-2022
Recall number
Z-0043-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
5, 345 KIts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 6 of 28

ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510

Z-0044-2022
Recall number
Z-0044-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
11 UNITS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 7 of 28

ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213

Z-0045-2022
Recall number
Z-0045-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
6,395 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 8 of 28

ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220

Z-0046-2022
Recall number
Z-0046-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
333 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 9 of 28

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

Z-0047-2022
Recall number
Z-0047-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
33,066 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 10 of 28

Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282

Z-0048-2022
Recall number
Z-0048-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
20,475 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 11 of 28

Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275

Z-0049-2022
Recall number
Z-0049-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
13,935 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 12 of 28

Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527

Z-0050-2022
Recall number
Z-0050-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
1,256 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 13 of 28

Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075534

Z-0051-2022
Recall number
Z-0051-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
188 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 14 of 28

Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541

Z-0052-2022
Recall number
Z-0052-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
98 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 15 of 28

Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305

Z-0053-2022
Recall number
Z-0053-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
1,733 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 16 of 28

Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173

Z-0054-2022
Recall number
Z-0054-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
2,833 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 17 of 28

Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180

Z-0055-2022
Recall number
Z-0055-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
3,425 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 18 of 28

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

Z-0056-2022
Recall number
Z-0056-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 19 of 28

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

Z-0057-2022
Recall number
Z-0057-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
58 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 20 of 28

Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)

Z-0058-2022
Recall number
Z-0058-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
16 bundles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 21 of 28

Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)

Z-0059-2022
Recall number
Z-0059-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
55 bundles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 22 of 28

Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)

Z-0060-2022
Recall number
Z-0060-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
42 bundles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 23 of 28

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

Z-0061-2022
Recall number
Z-0061-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
334 bundles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 24 of 28

Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)

Z-0062-2022
Recall number
Z-0062-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
79 bundles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 25 of 28

Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

Z-0063-2022
Recall number
Z-0063-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
144 bundles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 26 of 28

Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

Z-0064-2022
Recall number
Z-0064-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
1,122 bundled kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 27 of 28

Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

Z-0065-2022
Recall number
Z-0065-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
579 bundled kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.

device · product 28 of 28

Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

Z-0066-2022
Recall number
Z-0066-2022
Initiated
August 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
322 BUNDLE KITS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Code information

All Lots

Distribution pattern

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.