FDAJune 14, 2021device
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
What to do
FDA enforcement status: Terminated
Brands named
roi cpsroi
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAregard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.2024-12-26
- FDAregard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 8002230092024-07-24
- FDARegard Kit containing the Microtek decanter2024-06-17
- FDAregard Operative LAP, Item Number 800943001; surgical convenience kit2023-12-18
- FDARegard Dressing change kit, Item Number 8000260062023-11-20
- FDARegard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit2023-09-21
- FDAGS0008 2Y - Burn Pack - STL, Item Number 8800820252023-09-11
- FDASterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number...2023-03-22
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