The Recall Desk
HighFDA (Devices)·Z-1371-2022·Announced 2022-07-20

Hemodialysis Dialysate Recalled for Unqualified Bottle Caps

Fresenius Medical Care is recalling NATURALYTE Liquid Acid dialysate because bottle caps are not qualified for use. The recall affects 163 cases of lot 22CTAC102 distributed nationwide.

What this means for you

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: FDA Class II medical device recall of a product used by vulnerable dialysis patients. No illnesses or injuries have been reported, but the defective bottle caps pose a theoretical contamination risk in a critical care product.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling NATURALYTE Liquid Acid 3.0K 3.0Ca dialysate (Part Number 08-3301-2) because the bottle caps do not meet required specifications. The affected lot (22CTAC102, expiration March 31, 2024) contains bottles with alternate caps labeled 'Sealed for your Protection' on the foil that are not qualified for use.

NATURALYTE Liquid Acid dialysate is indicated for patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Unqualified caps may fail to provide proper sealing, posing a contamination risk to patients.

Approximately 163 cases were distributed nationwide. Healthcare facilities and patients should contact Fresenius Medical Care for guidance regarding affected product.

The recalled product

Product
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
Manufacturer
Fresenius Medical Care Holdings, Inc.
Category
Medical Device — Dialysate
Hazard
  • defective-cap
  • contamination-risk

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category