NxStage PureFlow-B Solution Bags Perimeter Seal Failure Risk
NxStage Medical Inc is recalling NxStage PureFlow-B Solution bags nationwide due to potential perimeter seal failure on the small chamber, which could cause electrolyte fluid to splash into the user's face when opening the peel seam to mix chambers before treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with a risk-of-harm defect (potential facial splash injury from fluid); no reported illnesses or injuries are stated in the source, making the hazard theoretical but not low-risk enough for Moderate.
Plain-English summary
NxStage Medical Inc is recalling NxStage PureFlow-B Solution bags distributed nationwide. The recalled product includes catalog numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, and RFP-456, affecting approximately 115,465 cases (230,930 units).
The recalled bags have a potential defect in the perimeter seal on the small chamber. If the seal fails, electrolyte fluid could splash into the face of the user when they attempt to open the peel seam to mix the two chambers prior to treatment.
Patients using affected lots should discontinue use and contact NxStage Medical Inc or speak with their healthcare provider. A complete list of affected lot numbers by catalog number is available through the FDA, and customers should verify their product against the specific UDI-DI numbers and lot numbers identified in the recall notice.
The recalled product
- Product
- NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
- Manufacturer
- NxStage Medical Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Q2407308
- Q2407147
- Q2407148
- Q2407149
- Q2407313
- Q2407386
- Q2407387
- Q2407388
- Q2407389
- Q2407063
- Q2407064
- Q2407065
- Q2407067
- Q2407068
- Q2407069
- Q2407070
- Q2407071
- Q2407217
- Q2407218
- Q2407219
Distribution
Distributed nationwide across the United States.
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