Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ6425

FDA device recall Z-1646-2023 · posted 2023-05-26 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

The kits were damaged by water.

Action taken

The recalling firm issued the recall letter dated 4/21/2023 via email on 4/21/2023. The letter informed the customer the packs were exposed to water, potentially affecting the sterility of the item, and that they should be destroyed for credit. The consignee was requested to immediately check their stock for the affected item number and the lot numbers listed on the recall portal. A link was provided to access the response form to list the quantity of affected product in inventory. Upon completion of the form, the consignee was to destroy the affected product. If the consignee is a distributor or have resold or transferred the product to another company or individual, they were to notify them of this recall communication and have the customer document and destroy any affected product.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OJH

Quantity affected

342 packs (114 packs/product)

Distribution

Distribution was made to California. There was no foreign/government/military distribution.

Date initiated

2023-04-21

Date posted

2023-05-26

Location

Northfield, IL