Cardinal Health Recalls Presource Gyn Laparoscopy Kits Due to Airflow Obstruction Risk
Cardinal Health is recalling 4,571 Presource Gyn Laparoscopy 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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from…"
Plain-English summary
Cardinal Health, Medical Products & Services is recalling 4,571 units of the Presource PBDS, Gyn Laparoscopy Kit, Circulator. The affected 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 may become lodged in the filter. This can potentially cause an obstruction of airflow. The affected 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 return or replacement. The specific catalog number is PB24LSNPC01, and the affected lot numbers are 152737, 159630, 168459, 176674, 187217, 197319, and 840618.
The recalled product
- Product
- Presource PBDS, Gyn 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 (8)
- Catalog Number: PB24LSNPC01
- Lots: 152737
- 159630
- 168459
- 176674
- 187217
- 197319
- 840618
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
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- SevereCardinal Health Recalls Presource Knee Arthroscopy Kits Due to Airflow Obstruction Risk
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