CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Summary
The FDA issued a Class II for CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE by Terumo Cardiovascular Systems Corporation. Reason: Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result i.
Details
Source
Device Recall
External ID
Z-1346-2023
Action Date
2023-04-12
Status
Ongoing
Category
device
Product Description
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Lot/Code Info: UDI-DI: (01)00699753450868; Lot Number AM03
Quantity Affected: 84 units
Reason for Recall
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
Distribution
US Nationwide. Belgium, Canada, Costa Rica, Thailand.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-01
Company
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 130 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Terumo Cardiovascular Systems Corporation has 10 FDA actions in our database, including 7 recalls and 3 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 (Terumo Cardiovascular Systems Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Terumo Cardiovascular Systems Corporation have FDA actions?
Terumo Cardiovascular Systems Corporation has 10 FDA actions in our database, including 7 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1346-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29