NATURALYTE Hemodialysis Dialysate Recalled Due to Unqualified Bottle Caps
Fresenius Medical Care is recalling 656 cases of NATURALYTE Liquid Acid dialysate nationwide (lot 22CTAC106) because alternate bottle caps are not qualified for use, potentially compromising product integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. However, the unqualified bottle caps on a critical hemodialysis dialysate product represent a risk-of-harm scenario where product integrity could be compromised for patients dependent on this essential medical device.
Plain-English summary
Fresenius Medical Care Holdings, Inc., is recalling NATURALYTE Liquid Acid 2.0K 2.5Ca, a dialysate solution indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. The recall affects 656 cases distributed nationwide with lot number 22CTAC106 and an expiration date of March 31, 2024.
The recall was initiated because alternate bottle caps labeled with "Sealed for your Protection" on the foil are not qualified for use with this product. Unqualified caps may not provide adequate seal integrity for the dialysate.
Dialysis patients and healthcare providers should contact Fresenius Medical Care for instructions regarding affected product disposition and replacement. Patients undergoing hemodialysis should not interrupt treatment without consulting their healthcare provider.
The recalled product
- Product
- NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Dialysate
- Affected units
- 656
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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