The Recall Desk
SevereFDA (Devices)·Z-1199-2013·Announced 2013-05-15

Cardinal Health Recalls Presource PBDS Kits Due to Airflow Obstruction Risk

Cardinal Health is recalling 4,571 Presource PBDS kits because plastic packaging remnants may lodge in the filter and obstruct airflow.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall, which per the rubric mandates a minimum score of 4 (Severe) due to the potential for serious adverse health consequences from airflow obstruction.

Plain-English summary

Cardinal Health, Medical Products & Services is recalling 4,571 units of the Presource PBDS, Hand, Kit, Circulator. The recall involves specific lots (856515, 875680, 894983, 905021, 929987, 932368, 946822, 954543, 968547) with Catalog Number PO24HKGWG01. These kits were distributed in Arkansas, Mississippi, South Carolina, and Tennessee.

The recall is due to a potential defect where outer plastic packaging on components may leave remnants in the filter if removed without disassembling the components. These remnants could potentially cause an obstruction of airflow. The FDA has classified this as a Class I recall.

Healthcare providers and consumers should stop using the affected kits immediately and contact Cardinal Health for instructions on return or replacement. Do not use the product if the packaging has been removed in a manner that could leave plastic remnants in the filter.

The recalled product

Product
Presource PBDS, Hand, Kit, Circulator
Affected units
4,571

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 (10)

  • Catalog Number: PO24HKGWG01
  • Lots: 856515
  • 875680
  • 894983
  • 905021
  • 929987
  • 932368
  • 946822
  • 954543
  • 968547

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 14 recalled by Cardinal Health, Medical Products & Services 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 14 products in this recall →