Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000

FDA device recall Z-2206-2023 · posted 2023-07-20 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.

Action taken

The recalling firm issued letters dated 5/12/2023 via first class mail and email on 5/12/2023. The letter explained the reason for recall and provided the required actions. The actions were to immediately check their inventory for the affected item number and lot numbers listed on the recalling firm's recall portal and destroy the products. A website link is provided for completing the response form and for obtaining the specific item and lot numbers affected. Once the response form is submitted, the consignee account will be credited. Distributors are instructed to notify the customers of the recall who have received the affected product and the customer is to document the destruction of their product. The distributor is to include the customer product quantities in their response form.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HRR

Quantity affected

189,221 scissors

Distribution

US Nationwide distribution. There was government distribution but no military or foreign distribution.

Date initiated

2023-05-12

Date posted

2023-07-20

Location

Northfield, IL