The Recall Desk
HighFDA (Devices)·Z-2087-2021·Announced 2021-07-28

NaturaLyte Bicarbonate Concentrate Recalled After Freezing Temperature Exposure

NaturaLyte Dry Bicarbonate Concentrate, used in hemodialysis machines to prepare dialysate, was recalled after exposure to freezing temperatures during transport. The affected lot (21ATBC004) was distributed to facilities in Texas only.

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: This is a medical device component used in dialysate for hemodialysis, a risk-of-harm product. Although no illnesses or injuries have been reported, the product may be degraded from freezing temperature exposure during transport.

Plain-English summary

Fresenius Medical Care Holdings, Inc. has recalled NaturaLyte Dry Bicarbonate Concentrate (Lot Number 21ATBC004), a component used to prepare dialysate in hemodialysis machines. The product was exposed to freezing temperatures due to refrigerated truck malfunctions during transportation.

The 120-bag shipment was distributed to medical facilities in Texas only. The FDA has classified this recall as a Class II issue.

The recalled product

Product
NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formula
Manufacturer
Fresenius Medical Care Holdings, Inc.
Category
Medical Device — Dialysis Equipment Component
Hazard
  • freezing-damage
  • product-stability

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 21ATBC004 UDI: (01)00840861101955

Distribution

Distributed in 1 state:

  • TX

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