CLASS II ONGOING Device recall · Reported 1 Mar 2023 · FDA Enforcement Report

Medline Sterile Hand Pack recalled by MEDLINE INDUSTRIES, LP

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Sterile Hand Pack, distributed nationwide in the US. The recall was initiated on 27 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(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.

Quantity recalled1,689 trays

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1163-2023
FDA event ID: 91457
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 27 Dec 2022
FDA classified: 23 Feb 2023
Reported: 1 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

27 Dec 2022	Recall initiated by company
23 Feb 2023	Classified by FDA	+58 days
1 Mar 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

(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.

Where it was distributed

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

Nationwide Arkansas Colorado Georgia

Questions about this recall

Is Medline Sterile Hand Pack recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Sterile Hand Pack on 27 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-1163-2023.

Why was it 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.

Which lots are affected?

(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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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