MEDLINE INDUSTRIES, LP Northfield Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The kits were damaged by water.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

CA