Device product

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

Z-3159-2024

July 24, 2024

Class II

Product summary

Firm: ROi CPS LLC
Event: Event 95229
Status: Ongoing
Classification: Class II
Quantity: 3387 kits
Official record key: device-enforcement:Z-3159-2024

Official wording

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

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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