Recall Z-2847-2016

Carefusion 2200 Inc · initiated June 29, 2016

Class II Terminated

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, Broselow Complete Set of Colored Pouches, Product Code 7730MOD

Codes / lots: Lot numbers 914873, 914876, and 914878 of the individual modules (7700RAW), which are contained in Lot number 916714 of the Broselow Complete Set of Colored Pouches, Product Code 7730MOD. Expiration Date MAR 2018.

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-2847-2016
Initiated
June 29, 2016
Terminated
March 2, 2018
Product code
CAE – Airway, Oropharyngeal, Anesthesiology
Quantity
50 units
Distribution
Illinois
Recalling firm
Carefusion 2200 Inc, Vernon Hills, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2846-2016 Class IIBroselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK…The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the… 06/29/2016Terminated