Broselow Pediatric Emergency System Pouches Recalled for Incorrect Airway Size
Carefusion 2200 Inc is recalling Broselow Pediatric Emergency System pouches because the PINK/RED Oxygen Delivery Module contains 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 and is a voluntary precautionary action for a packaging error involving a medical device component size mismatch, with no reported injuries or illnesses in the source text.
Plain-English summary
Carefusion 2200 Inc is conducting a voluntary Field Safety Corrective Action for the Broselow/Hinkle Pediatric Emergency System, specifically the Broselow Complete Set of Colored Pouches (Product Code 7730MOD). The recall affects 50 units distributed in Illinois. The specific issue involves the PINK/RED Oxygen Delivery Module (7700RAW), where the Oral Airway pouch is incorrectly packaged with an 8 cm Berman Oral Airway component, despite the pouch being labeled for a 5 cm component.
The PINK/RED Oxygen Delivery Module is intended for use within the PINK/RED Pouch of the Broselow pediatric safety system. The affected lots are 914873, 914876, and 914878 of the individual modules, which are contained in Lot number 916714 of the complete set. The expiration date for these units is March 2018.
Healthcare providers and consumers should check their inventory for the affected lot numbers and stop using the PINK/RED Oxygen Delivery Module if it matches the identified lots. The incorrect airway size may not be appropriate for the intended patient size associated with the PINK/RED color coding in the Broselow system.
The recalled product
- Product
- Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 50
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 (4)
- Lot numbers 914873
- 914876
- and 914878 of the individual modules (7700RAW)
- Product Code 7730MOD. Expiration Date MAR 2018.
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Carefusion 2200 Inc
See all →- HighEndoscopic surgical clamp recalled for defective rotation knob
FDA (Devices) · 2023-08-23
- HighSurgical Clamp Recall: Rotation Knob May Crack or Break
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical graspers recalled for potential rotation knob cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic Surgical Dissectors Recalled for Potential Rotation Knob Cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical graspers recalled for potential rotation knob failure
FDA (Devices) · 2023-08-23
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02