Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2846-2016.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2846-2016.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2846-2016.
Carefusion 2200 Inc
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report an adverse event to the FDA (MedWatch)
If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Carefusion 2200 Inc Recall FAQ
Carefusion 2200 Inc is the subject of a respiratory devices safety report: Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2. The notice was published on June 29, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 544 units are potentially affected.