CRANIOTOMY PACK, Pack Number DYNJ46552O

FDA device recall Z-3069-2024 · posted 2024-09-06 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

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.

Action taken

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.

Root cause

Process change control

Status

Open, Classified

Product code

OJH

Quantity affected

188 units

Distribution

US: TX, IL, CA

Date initiated

2024-06-18

Date posted

2024-09-06

Location

Northfield, IL