ROi CPS LLC: Medical Device Recall in 2024 - (Recall #: Z-3159-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 24, 2024

Date Posted: September 25, 2024

Recall Number: Z-3159-2024

Event ID: 95229

Reason for Recall:

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

Status: Ongoing

Product Quantity: 3387 kits

Code Information:

GTIN 10194717114116, Lot Numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, 96833RS

Distribution Pattern:

US Nationwide distribution in the state of North Carolina.

Voluntary or Mandated:

Voluntary: Firm initiated