—#197868

Product

(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and (2) Medline Sterile Hand Pack, Item DYNJ63380C, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS.

FDA product code: OJH — Orthopedic Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: (1) UDI/DI (01) 40193489230339; Lot numbers 21DLA284, exp. 10/31/2023; 21BLA250, exp. 2/28/2023; 20JLA617, exp. exp. 2/28./2023; 20ILA666, exp. 2/28/2023; 20ILA518, exp. 2/28/2023; 20ILA217, exp. 2/28/2023; and 20ILA054, exp. 11/30/2022. (2) UDI/DI (01) 40193489956895; Lot numbers 21HLA016, exp. 12/31/2023; 21ILA354, exp. 12/31/2023; 21JLA196, exp. 12/31/2023; 21KLA245, exp. 1/31/2024; 21LLA141, exp. 1/31/2024; 22ALA377, exp. 1/31/2024; 22CLB011, exp. 12/31/2023; 22ELA046exp. 6/30/2024; and 22FLA125, exp. 1/31/2024.

Why it was recalled

The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Recall letters dated 12/27/2022 were issued via email on 12/27/2022 or via U.S. mail for customers who haver not previously used the Medline Recall Portal. The customer was informed of the issue and told that any affected kits found are to be stickered with labels indicating to remove and replace the affected component from a different sterile supply and return the kit to the customer inventory. The remaining components are acceptable for use. If the customer has the affected kits, they are to indicate the quantity on the response and stickers will be sent to them for placement on the kits. The customer is requested to immediately check their stock for the affected item and lot numbers listed on the recall portal and quarantine the product. The customer is to use the website link in the letter to complete the response form. (The website link contains the specific item and lot numbers that are being recalled.) The quantity of affected product in inventory is to be reported on the response form. Upon receipt of the response form, the customer will receive over-labels via FedEx overnight to affix to the affected kits. If the customer is a distributor or the customer has resold or transferred the product to another company or individual, they are to notify their customer of the recall communication. These downstream customers are to return any affected product to the distributor (or to whoever resold/transferred the product) for collection and return to Medline.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.

Timeline

Recall initiated: 2022-12-27
Posted by FDA: 2023-02-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197868. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.