Reported Mar 7, 2018 · Terminated
NxStage Dialysate Sack
NxStage Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NxStage Medical, Inc. · 350 Merrimack Street · Lawrence, MA · 01843-1748
Is this the product you have?
NxStage Dialysate Sack
9 of 9 products
| Model / number | Product as published |
|---|---|
SAK-301 | UDI-M535SAK3010 |
SAK-302 | UDI-M535SAK3020 |
SAK-303 | UDI-M535SAK3030 |
SAK-304 | UDI-M535SAK3040 |
SAK-306 | UDI-M535SAK3060 |
SAK-307 | UDI- M535SAK3070 |
SAK-402 | UDI-M535SAK4020 |
SAK-405 | UDI- M535SAK4050 |
SAK-407 | REF SAK-406 UDI-M535SAK4060 & UDI- M535SAK4070 Hemodialysis systems and accessories |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot # 70879245, Exp Date 7/11/2019 SAK-302 2 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 3 Lot # 70979110, Exp Date 7/24/2019 SAK-307- Lot #'s 70879187 & 71079144, Exp Date 8/27/2019 SAK-402 4 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 - Amount recalled
- 16,039 cases/2 units
Where it was sold
- Nationwide
Why it was recalled
May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new NxStage Medical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.