—#209518

Product

KIT PEDI CRANI LAMI, Pack Number DYNJ907372A

FDA product code: OJH — Orthopedic Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI/DI Case 40195327060412, UDI/DI Each 10195327060411; Lot Numbers: 23ILA372, 23ILA184, 23HLB240, 23HLA567, 23HLA126, 23ELA634, 23DLA974, 23ALA995, 22JLA577, 22HLA985, 22HLA379, 22GLB224, 22GLB099, 22GLA383, 22GLA171, 22DLA615, 22CLA957, 22ALA965, 22ALA325

Why it was recalled

A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.

Root cause (FDA determination)

Process change control

Action the firm took

Medline Industries issued a Recall notice to its consignees on 06/18/2024 via email. The notice explained the issue, potential risk, and directed the product to be stickered to instruct the used to remove the recalled component from the kit and replace from sterile supply. Distributors or those who have transferred the product were directed to notify those to whom the product was distributed of the recall. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US: TX, IL, CA

Timeline

Recall initiated: 2024-06-18
Posted by FDA: 2024-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209518. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.