The Recall Desk
HighFDA (Devices)·Z-1311-2022·Announced 2022-07-13

NaturaLyte 2301 dialysate recalled for storage exposure and leaks

Fresenius Medical Care recalled NaturaLyte 2301 dialysate in Texas and Louisiana after exposure to below-recommended storage temperatures. The exposure may cause packaging leaks, potentially leading to biological contamination and bloodstream infection risk.

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 with no reported illnesses or injuries. The hazard is serious (bloodstream infection risk from biological contamination) but theoretical. This meets the 'High' criterion: risk-of-harm product where injury has not yet been reported.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal dialysate (Model No. 08-2301-3) distributed in Texas and Louisiana. The recall involves three cases with lot number 21AGAC009.

The product was exposed to storage temperatures below the manufacturer's recommended levels, which may cause leaks in the packaging. Leaking packages can allow biological contamination of the dialysate, increasing the risk of potential bloodstream infection in patients using the product.

The recalled product

Product
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Manufacturer
Fresenius Medical Care Holdings, Inc.
Category
Medical Device — Dialysate
Hazard
  • packaging-leak
  • biological-contamination
  • bloodstream-infection-risk

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)

  • UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009

Distribution

Distributed nationwide across the United States.

Related recalls

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