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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Cardinal Health, Medical Products & Services
- Category
- Medical Device — Surgical Kits
- 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
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
See all →- SevereCardinal Health Recalls Presource Total Knee Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
- SevereCardinal Health Recalls Presource Anesthesia Circuit Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
- SevereCardinal Health Recalls Presource Total Hip Kits Due to Airflow Risk
FDA (Devices) · 2013-05-15
- SevereCardinal Health Recalls Presource Knee Arthroscopy Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
- SevereCardinal Health Recalls Presource PBDS Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
Same hazard · airflow obstruction
See all →- SevereVyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Airflow Obstruction Risk
FDA (Devices) · 2018-08-15
- SevereVyaire Medical Recalls AirLife Adult Resuscitation Devices Due to Airflow Obstruction
FDA (Devices) · 2018-08-15
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