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Terminated

Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD

FDA Recall Z-2847-2016 · Posted None

Recalling FirmCarefusion 2200 Inc
Recall StatusTerminated
Product CodeCAE
Date Initiated2016-06-29
Date Terminated2018-03-02
Product Quantity50 units

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.

Firm Action

Recall notices were sent 6/29/2016.

Root Cause

Under Investigation by firm

Distribution Pattern

Illinois

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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