Z-2846-2016 Class II Terminated
FDA device recall Z-2846-2016 was initiated by Carefusion 2200 Inc on Jun 29, 2016 and is designated Class II. 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… The recall status is terminated (terminated Mar 2, 2018). Affected quantity: 544 (2/PACKS).
Recall Details
- Product Type
- Devices
- Report Date
- Sep 28, 2016
- Initiation Date
- Jun 29, 2016
- Termination Date
- Mar 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 544 (2/PACKS)
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.
Distribution Pattern
Illinois
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2846-2016
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026