← Every firm
ZOLL Circulation, Inc. FDA Recalls
30 recalls on file across devices, 1 of them Class I and 2 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (CClass IMar 4, 2025AutoPulse NXT Resuscitation System may not provide adequate |
| AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPRClass IISep 22, 2022Due to increase in Li-Ion Battery failures |
| ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capaClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venoClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New LuerClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilitiClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabiClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venousClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STEClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capaClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venousClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)Class IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)Class IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabiClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with Class IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilitiClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabiClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New LuerClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)Class IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)Class IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilitiClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)Class IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, SterileClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilitieClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venousClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New LuerClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New LuerClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |
| Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central veClass IIAug 6, 2021Labeling update concerning potential leaks from the cathete |