The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1146-2022·Announced 2022-06-08

FDA recalls APD Drain Manifold units lacking regulatory clearance

Baxter Healthcare is recalling 180 APD Drain Manifold units distributed in nine US states because certain product codes lack FDA regulatory clearance. Patients using affected units should contact Baxter Healthcare immediately.

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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory non-compliance (lack of FDA clearance) rather than a demonstrated safety defect, making this a precautionary regulatory recall without reported patient harm.

Plain-English summary

Baxter Healthcare Corporation is recalling the APD Drain Manifold medical device. The recall involves 180 units that were distributed across nine US states: California, Missouri, Massachusetts, Arizona, Texas, Florida, New York, Maryland, and Ohio.

The reason for this recall is that certain product codes lack FDA regulatory clearance. The affected units were distributed within the United States in error because they did not have the required FDA approval before being released to market.

Patients currently using affected units should stop using them and contact Baxter Healthcare Corporation immediately. Healthcare providers should verify that any APD Drain Manifold units in their facilities are not part of this recall by checking the product codes and lot numbers against the recall information provided by Baxter.

The recalled product

Product
APD Drain Manifold
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Peritoneal Dialysis Equipment
Hazard
Affected units
180

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 (6)

  • Product code: R5C4512
  • UDI: 00085412008790
  • Lot Number: H18D03030 (exp. date: 04/03/2023)
  • Lot Number: H18E31046 (exp. date: 05/31/2023)
  • Lot Number: H18L04065 (exp. date:12/04/2023)
  • Lot Number: H20H10073 (exp. date: 08/10/2022)

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Baxter Healthcare Corporation 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.

See all 6 products in this recall →

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