MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049

FDA device recall Z-2595-2023 · posted 2023-09-18 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.

Action taken

Medline Industries issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem with the device, the potential hazard, and requested the following: Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. Distributors or those who resold or transferred the product were directed to notify their customers and have them destroy any affected product. If you have any questions, please contact the Recall Department at 866-359-1704.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JOK

Quantity affected

324,451 devices

Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore

Date initiated

2023-08-03

Date posted

2023-09-18

Location

Northfield, IL