Recall Z-1739-2022— Isopure Corp
Class II · Terminated
Class II FDA medical device recall by Isopure Corp, initiated 2022-07-26, terminated 2024-05-31. It names one FDA 510(k) clearance: K120005. Product: 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. Reason: Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching.
- Recalling firm
- Isopure Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-07-26
- Terminated
- 2024-05-31
- Firm location
- Louisville, KY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
Data sourced from openFDA. This site is unofficial and independent of the FDA.