Recall Z-2846-2016— Carefusion 2200 Inc
Class II · Terminated
Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2016-06-29, terminated 2018-03-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2. Reason: The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm Berman Oral Airway component. Therefore, the component within the pouch is incorrect. The PINK/RED Oxygen Delivery Module, 7700RAW, is intended to be used within the PINK/RED Pouch of the BROSELOW pediatric safety system. Three (3) lots (lot# 914873, lot# 914876 and lot #914878) of the PINK/RED Oxygen Delivery Module, 7700RAW, are affected by this voluntary Field Safety Corrective Action..
- Recalling firm
- Carefusion 2200 Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-29
- Terminated
- 2018-03-02
- Firm location
- Vernon Hills, IL, United States
Product description
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Reason for recall
The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm Berman Oral Airway component. Therefore, the component within the pouch is incorrect. The PINK/RED Oxygen Delivery Module, 7700RAW, is intended to be used within the PINK/RED Pouch of the BROSELOW pediatric safety system. Three (3) lots (lot# 914873, lot# 914876 and lot #914878) of the PINK/RED Oxygen Delivery Module, 7700RAW, are affected by this voluntary Field Safety Corrective Action.
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