—#200872

Product

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

FDA product code: HRR — Scissors, Orthopedic, Surgical
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot numbers and UDI numbers: 23BBI031, 01100801968242291023BBI031; 23BBK353, 01100801968242291023BBK353; 23BBP830, 01100801968242291023BBP830; 23BBQ676, 01100801968242291023BBQ676; 23BBR546, 01100801968242291023BBR546; 23CBH009, 01100801968242291023CBH009; 23CBL930, 01100801968242291023CBL930; 23CBP165, 01100801968242291023CBP165; 23BBS369, 01100801968242291023BBS369; 23BBT718, 01100801968242291023BBT718; 23CBV064, 01100801968242291023CBV064; 23CBW834, 01100801968242291023CBW834; 23CBV222, 01100801968242291023CBV222; 23CBW020, 01100801968242291023CBW020; and 23CBQ190, 01100801968242291023CBQ190.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2023-05-12
Posted by FDA: 2023-07-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #200872. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.