Carefusion Recalls Pediatric Oxygen Delivery Modules Due to Incorrect Airway Size
Carefusion 2200 Inc is recalling Broselow/Hinkle Pediatric Emergency System Oxygen Delivery Modules because they contain an 8 cm airway instead of the labeled 5 cm size.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a packaging error resulting in the wrong size of a medical component, which is a significant quality issue but does not involve reported injuries or deaths, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Carefusion 2200 Inc is conducting a voluntary Field Safety Corrective Action for the Broselow/Hinkle Pediatric Emergency System, PINK/RED Oxygen Delivery Module (Product Code 7700RAW2). The recall involves 544 units (2/packs) distributed in Illinois. The affected lot numbers for the individual modules are 914873, 914876, and 914878, which are contained in Lot number 914867 of the 2/pack. The expiration date for these units is January 2021.
The recall was initiated because the Oral Airway pouch within the PINK/RED Oxygen Delivery Module was incorrectly packaged. Although the pouch is correctly labeled as containing a 5 cm Berman Oral Airway, it actually contains an 8 cm Berman Oral Airway component. This discrepancy means the component within the pouch is incorrect for the intended use within the PINK/RED Pouch of the Broselow pediatric safety system.
Healthcare providers and consumers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be removed from use and returned to the manufacturer or a designated distributor for replacement or refund, in accordance with the Field Safety Corrective Action.
The recalled product
- Product
- Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
- Manufacturer
- Carefusion 2200 Inc
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 (3)
- Lot numbers 914873
- 914876
- and 914878 of the individual modules (7700RAW)
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Carefusion 2200 Inc 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.
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