FDAJuly 24, 2024device
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
What to do
FDA enforcement status: Ongoing
Brands named
roi cpsroi
UPCs
10194717114116
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 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
- FDASterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. reg...2023-03-22
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →