|
Class 2 Device Recall Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM |
|
Date Initiated by Firm |
June 29, 2016 |
Create Date |
September 20, 2016 |
Recall Status1 |
Terminated 3 on March 02, 2018 |
Recall Number |
Z-2847-2016 |
Recall Event ID |
74647 |
Product Classification |
Airway, oropharyngeal, anesthesiology - Product Code CAE
|
Product |
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD |
Code Information |
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. |
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 |
50 units |
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.
|
|
|
|