NxStage Dialysate Sacks Recalled for Exceeding Endotoxin Quality Standards
NxStage Medical is recalling dialysate sacks because endotoxin levels may exceed the ANSI/AAMI quality standard of 0.5 EU/ml.
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: The recall involves a high-risk pathogen (endotoxin) in a medical device without reported illness, meeting the criteria for a High severity score.
Plain-English summary
NxStage Medical, Inc. is recalling specific lots of NxStage Dialysate Sacks used in hemodialysis systems. The recall involves 16,039 cases/2 units distributed nationwide in the United States, as well as in the United Kingdom and Spain.
The recall was initiated because the product may contain endotoxin levels that have been confirmed to exceed the ANSI/AAMI quality standard for dialysis fluid of 0.5 EU/ml when used to prepare the product. The affected reference numbers include SAK-301, SAK-302, SAK-303, SAK-304, SAK-306, SAK-307, SAK-402, SAK-405, SAK-406, and SAK-407, with specific lot numbers and expiration dates listed in the agency's structured data.
Healthcare facilities and consumers should stop using the affected dialysate sacks and contact NxStage Medical, Inc. for instructions on return or replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI…
- Manufacturer
- NxStage Medical, Inc.
- Category
- Medical Device — Dialysis
- Hazard
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 (14)
- SAK-301- Lot # 70879245
- Exp Date 7/11/2019 SAK-302- Lot # 71079056
- Exp Date 7/30/2019 SAK-303- Lot #'s 70879181 & 70879224
- SAK-304- Lot #'s 70779236
- 70879045
- 70879105
- 70879220 & 70979066
- Exp Date 7/8/2019 SAK-306- Lot # 70979110
- Exp Date 7/24/2019 SAK-307- Lot #'s 70879187 & 71079144
- Exp Date 8/27/2019 SAK-402- Lot # 70879235
- Exp Date 7/11/2019 SAK-405- Lot #'s 70779202 & 70879233
- Exp Date 7/9/2019 SAK-406- Lot #'s 70979253
- Exp Date 7/29/2019 SAK-407- Lot #'s 70879236
- Exp Date 7/11/2019
Distribution
Distributed nationwide across the United States.
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