FDA Medical Device Recalls (openFDA)
Carefusion 2200 Inc: Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
- Recall number
- Z-2847-2016
- Recalling firm
- Carefusion 2200 Inc
- Product
- Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
- Status
- Terminated
- Initiated
- 2016-06-29
- Posted
- not on file
- Terminated
- 2018-03-02
- Reason
- 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
- Under Investigation by firm
- Action
- Recall notices were sent 6/29/2016.
- Quantity
- 50 units
- Distribution
- Illinois
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAE
- Firm FEI
- 3008002452
- Firm city
- Vernon Hills
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28