PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 28, 2016 Initiated: June 29, 2016 #Z-2846-2016

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.

Details

Recalling Firm
Carefusion 2200 Inc
Units Affected
544 (2/PACKS)
Distribution
Illinois
Location
Vernon Hills, IL

Frequently Asked Questions

What product was recalled?
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2. Recalled by Carefusion 2200 Inc. Units affected: 544 (2/PACKS).
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 28, 2016. Severity: Moderate. Recall number: Z-2846-2016.