The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1523-2013·Announced 2013-06-19

Fenwal Recalls AMICUS Exchange Kits Due to Labeling Error

Fenwal is voluntarily recalling 114 AMICUS Exchange Kits because the product was cleared for European use only but distributed in the US.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly identifies the issue as a labeling error regarding market clearance rather than a physical defect or contamination. No injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Fenwal Inc has initiated a voluntary urgent product recall for 114 units (19 cases) of AMICUS Exchange Kits, product code R4R239, lot FA12C07070. These kits are designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure.

The recall was initiated because the specific batch was cleared for European use only but was distributed within the United States market. The source text identifies the issue as a labeling error where the written description for the s[ource text truncated] was missing or incorrect, resulting in the product being sold in a market where it was not fully cleared.

The affected product was distributed nationwide in the USA. Consumers and healthcare facilities should stop using the affected kits and contact Fenwal Inc for further instructions or a return.

The recalled product

Product
AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
Manufacturer
Fenwal Inc
Category
Medical Device — Plasma Exchange
Hazard

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 (3)

  • Model No.: R4R2339
  • Lot No.: FA12C07070
  • Expiration Date: 03/2014

Distribution

Distributed nationwide across the United States.

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