NxStage Cartridge Express with Speedswap recall
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised…
Why was NxStage Cartridge Express with Speedswap recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI M535CAR5350; Package DI M535CAR5355 Lots 20878001, 30978013, 30978032, 31178011, 31178019
- Product
- NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised…
- Recalling firm
- NxStage MDS Corporation
- Quantity
- 693
- 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.
- Recall date
- March 6, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)