FDA Enforcement
Class II
Terminated
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
Recall: Z-0887-2016
·
Reported March 2, 2016
Enforcement
- Recall Number
- Z-0887-2016
- Event ID
- 73077
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 2, 2016
- Initiation Date
- January 18, 2016
- Classification Date
- February 25, 2016
- Termination Date
- August 14, 2017
- Address
- 920 Winter St, N/A, Waltham, MA, 02451-1521, United States
Description
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
Reason
On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.
Code Info
Lot Number: 15STAC072 Exp Date: 2017-12-31
Distribution
US Distribution to states of: KS, LA, MS, OK, and TX.
Quantity
848 (212 cases)