Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT,

FDA device recall Z-2703-2024 · posted 2024-08-22 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Action taken

Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OGR

Quantity affected

6998 units

Distribution

Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Date initiated

2024-03-22

Date posted

2024-08-22

Location

Northfield, IL