The Recall Desk
HighFDA (Devices)·Z-1194-2013·Announced 2013-05-15

Cardinal Health Recalls Presource Lap Chole Kits Due to Airflow Obstruction Risk

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

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: The recall involves a medical device where a defect (airflow obstruction) poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cardinal Health, Medical Products & Services is recalling 4,571 Presource PBDS Lap Chole Kits. The affected products are distributed in Arkansas, Mississippi, South Carolina, and Tennessee. The kits contain a pre-assembled Filter and Anesthesia Circuit that may have outer plastic packaging on one or more components.

The recall is issued because if the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter. This can potentially cause an obstruction of airflow. The source text does not report any illnesses or injuries associated with this defect.

Healthcare facilities and consumers should stop using the affected kits and contact Cardinal Health for instructions on return or replacement. The affected catalog numbers are PG24LCGWG02 and PG24LCGWG, with specific lot numbers listed in the official recall notice.

The recalled product

Product
A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit
Manufacturer
Cardinal Health, Medical Products & Services
Category
Medical Device — Anesthesia Equipment
Hazard
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 (12)

  • A) Catalog Number: PG24LCGWG02
  • Lots: 153502
  • 162892
  • 170494
  • 180482
  • 88701
  • 193548
  • 198163
  • 206986
  • B) Catalog Number: PG24LCGWG
  • Lots:153502
  • 188701

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 →

Related recalls

Same manufacturer · Cardinal Health, Medical Products & Services

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Same hazard · airflow obstruction

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