Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centri...

FDA Device Recall #Z-0821-2020 — Class II — April 19, 2019

Recall Summary

Recall Number Z-0821-2020
Classification Class II — Moderate risk
Date Initiated April 19, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Isopure Corp
Location Louisville, KY
Product Type Devices
Quantity 15

Product Description

Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3

Reason for Recall

There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to solution, and thereby result in corrosion and the presence of iron.

Distribution Pattern

The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.

Lot / Code Information

ACDS UDI: (01)00852456007092; ACDS Serial Number AC-837874 with Pump SN 178745C18; ACDS Serial Number AC-834638 with Pump SN 180212D18; ACDS Serial Number AC-837654 with Pump SN 178324B18; ACDS Serial Number AC-837864 with Pump SN 178743C18; ACDS Serial Number AC-837664 with Pump SN 178322B18; ACDS Serial Number AC-838050 with Pump Serial Number 178752C18; ACDS Serial Number AC-838030 with Pump SN 178746C18; ACDS Serial Number AC-838020 with Pump SN 178748C18; ACDS Serial Number AC-838173 with Pump SN 178744C18; ACDS Serial Number AC-838143 with Pump SN 178325B18; ACDS Serial Number AC-838260 with Pump SN 180211D18; ACDS Serial Number AC-838740 with Pump SN 180209D18; ACDS Serial Number AC-838743 with Pump SN 180207D18; ACDS Serial Number AC-838749 with Pump SN 180215D18; ACDS Serial Number AC-838746 with Pump SN 180206D18

Other Recalls from Isopure Corp

Recall # Classification Product Date
Z-1739-2022 Class II Acidified Concentrate Distribution and Storage-... Jul 26, 2022
Z-1360-2022 Class II Isopure Sodium Bicarbonate Mixing and Distribut... Apr 28, 2022
Z-0822-2020 Class II Isopure Sodium Bicarbonate Mixing and Distribut... Apr 19, 2019
Z-0823-2020 Class II Finish Thompson Centrifugal Pump Model #110192-... Apr 19, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.