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U.S. Department of Health and Human Services

Class 2 Device Recall Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM

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  Class 2 Device Recall Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM see related information
Date Initiated by Firm June 29, 2016
Create Date September 20, 2016
Recall Status1 Terminated 3 on March 02, 2018
Recall Number Z-2846-2016
Recall Event ID 74647
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
Product Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Code Information 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.
Recalling Firm/
Manufacturer		 Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845
For Additional Information Contact Lindy Schenning
847-362-9303
Manufacturer 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 2		 Under Investigation by firm
Action Recall notices were sent 6/29/2016.
Quantity in Commerce 544 (2/PACKS)
Distribution Illinois
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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