NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and r
Summary
The FDA issued a Class II for NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory d by NxStage MDS Corporation. Reason: Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experien.
Details
Source
Device Recall
External ID
Z-1191-2024
Action Date
2024-03-06
Status
Ongoing
Category
device
Product Description
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.
Lot/Code Info: UDI-DI M535CAR5350; Package DI M535CAR5355 Lots 20878001, 30978013, 30978032, 31178011, 31178019
Quantity Affected: 693
Reason for Recall
Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious patient blood.
Distribution
US domestic distribution to Dialysis Centers located in AZ, CA, CO, GA, IL, IN, MA, MD, MI, MN, MO, MS, NC, NJ, NY, TN, TX, VA, WI. No international distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-29
Company
Lawrence, MA
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 205 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (NxStage MDS Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NxStage MDS Corporation have FDA actions?
This is the only FDA action we have on record for NxStage MDS Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1191-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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