The Recall Desk
SevereFDA (Devices)·Z-1206-2013·Announced 2013-05-15

Cardinal Health Recalls Presource Knee Arthroscopy Kits Due to Airflow Obstruction Risk

Cardinal Health is recalling 4,571 Presource Knee Arthroscopy 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 recall is classified as FDA Class I, which per the rubric mandates a minimum severity score of 4 (Severe) due to the potential for serious adverse health consequences.

Plain-English summary

Cardinal Health, Medical Products & Services is recalling 4,571 units of the Presource PBDS, Knee Arthroscopy, Kit, Circulator. The recall involves specific catalog number PO24KAGWE01 and lots 839276, 851503, 884374, 905171, 946381, 952446, and 959782. These kits were distributed in the states of Arkansas, Mississippi, South Carolina, and Tennessee.

The recall was initiated because the kits contain a pre-assembled Filter and Anesthesia Circuit that may have outer plastic packaging on one or more components. If this packaging is removed without disassembling the components, remnants of the plastic may become lodged in the filter. This can potentially cause an obstruction of airflow.

The U.S. Food and Drug Administration has classified this recall as Class I. Healthcare facilities and consumers who have these specific kits should stop using them and contact Cardinal Health for further instructions.

The recalled product

Product
Presource PBDS, Knee Arthroscopy, 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 (9)

  • Catalog Number: PO24KAGWE01
  • Lots: 839276
  • 851503
  • 884374
  • 905171
  • 930617
  • 946381
  • 952446
  • 959782

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 →