Recall Z-3159-2024— ROi CPS LLC
Class II · Ongoing
Class II FDA medical device recall by ROi CPS LLC, initiated 2024-07-24. FDA's recall record names no specific 510(k) clearance for this event. Product: regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009. Reason: Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-24
- Firm location
- Republic, MO, United States
Product description
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Reason for recall
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.