—#148096

Product

Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2

FDA product code: CAE — Airway, Oropharyngeal, Anesthesiology
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Recall notices were sent 6/29/2016.

Recalling firm

Firm: Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

Distribution

Distribution pattern: Illinois

Timeline

Recall initiated: 2016-06-29
Terminated: 2018-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148096. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.