Medical device recalls Moderate risk

ROi CPS LLC recalls regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

Recall date
July 24, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3159-2024
FDA classification
Class II
Brand / firm
ROi CPS LLC
Sold / distributed
US Nationwide distribution in the state of North Carolina.

Why it was recalled

Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

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