Cardinal Health Recalls Presource PBDS General Laparoscopy Kits
Cardinal Health is recalling 4,571 Presource PBDS General Laparoscopy Kits because plastic packaging remnants may obstruct airflow in the filter.
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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Cardinal Health, Medical Products & Services is recalling 4,571 units of the Presource PBDS, General Laparoscopy, Kit, Circulator. The recall is due to a risk that outer plastic packaging on pre-assembled components may leave remnants lodged in the filter if removed without disassembling the parts, potentially causing an obstruction of airflow.
The affected kits are identified by Catalog Number PG24LGNPC01 and include lots 147492, 152554, 160275, 165822, 173745, 180700, 186904, 195042, 205901, and 836989. These products were distributed in the states of Arkansas, Mississippi, South Carolina, and Tennessee.
Healthcare facilities should stop using the affected kits and contact Cardinal Health for instructions on how to return or dispose of the products.
The recalled product
- Product
- Presource PBDS, General Laparoscopy, 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 (11)
- Catalog Number: PG24LGNPC01
- Lots: 147492
- 152554
- 160275
- 165822
- 173745
- 180700
- 186904
- 195042
- 205901
- 836989
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
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