Recall Z-2846-2016
Carefusion 2200 Inc · initiated June 29, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Codes / lots: Lot numbers 914873, 914876, and 914878 of the individual modules (7700RAW), which are contained in Lot number 914867 of the 2/PACK (7700RAW2). Expiration Date JAN 2021.
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.
FDA-determined cause: Under Investigation by firm
Action taken
Recall notices were sent 6/29/2016.
Details
- Recall number
- Z-2846-2016
- Initiated
- June 29, 2016
- Terminated
- March 2, 2018
- Product code
- CAE – Airway, Oropharyngeal, Anesthesiology
- Quantity
- 544 (2/PACKS)
- Distribution
- Illinois
- Recalling firm
- Carefusion 2200 Inc, Vernon Hills, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2847-2016 Class II | Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches…The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the… | 06/29/2016Terminated |