FDA Enforcement
Class II
Ongoing
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Recall: Z-1371-2022
·
Reported July 20, 2022
Enforcement
- Recall Number
- Z-1371-2022
- Event ID
- 90438
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 20, 2022
- Initiation Date
- May 31, 2022
- Classification Date
- July 12, 2022
- Address
- 920 Winter St Bld 950, Waltham, MA, 02451-1521, United States
Description
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Reason
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
Code Info
UDI-DI: (01) 10840861101757 (17) 240331 (10) 22CTAC102 Lot Number: 22CTAC102 Exp Date: 2024-03-31
Distribution
Natiowide
Quantity
163 cases