Z-2846-2016Class II

Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2

Name: Z-2846-2016 Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Creator: Carefusion 2200 Inc
Published: 2016-06-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-06-29 / Terminated / root cause: labeling and UDI

FDA source

Carefusion 2200 Inc began a recall of Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2 on 2016-06-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2846-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-29
Posted: 2016-09-20
Terminated: 2018-03-02
Recalling firm: Medtronic, Inc.
Product: Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Product code: CAE Airway, Oropharyngeal, Anesthesiology
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Recall notices were sent 6/29/2016.
Quantity in commerce: 544 (2/PACKS)
Distribution: Illinois
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2846-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2846-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-20
Z-2847-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-20

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)