7 results
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34ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012. Manufactured by: Isopure Corp, Simpsonville, KY System is used to mix and distribute bicarbonate as a part of a clinical dialysis system.
FDA Recall
Terminated
·Isopure Corp·Product code FJP·May 19, 2011
Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
FDA Recall
Terminated
·Isopure Corp·Product code KPO·April 19, 2019
Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294. The Step 2, 3000-2000 GPD chemical is used in the cleaning procedures for the Isopure MD400 Series Reverse Osmosis System. Step
FDA Recall
Terminated
·Isopure Corp·Product code KPO·October 24, 2011
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Recall
Terminated
·Isopure Corp·Product code KPO·July 26, 2022
Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
FDA Recall
Terminated
·Isopure Corp·Product code N/A·April 19, 2019
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA Recall
Open, Classified
·Isopure Corp·Product code FIN·April 28, 2022
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
FDA Recall
Terminated
·Isopure Corp·Product code FIN·April 19, 2019