Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-

FDA device recall Z-1128-2023 · posted 2023-02-10 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Action taken

The firm sent a correction notice to its direct consignees on 12/07/2022 by US mail and email. The notice explained the issue and requested the following: "Please check you stock for affected kits and over-labeling will be sent to place on kits to ensure that all labeling is accurate. No kits are to be returned back to Medline. All components are not affected. Our records indicate that these were used as a component in the list of kit(s) purchased from Medline Industries, LP." "If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, LP." "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

OJH

Quantity affected

4779 units

Distribution

Nationwide

Date initiated

2022-12-07

Date posted

2023-02-10

Location

Northfield, IL