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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

MEDLINE INDUSTRIES, LP - Northfield: The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

Agency Publication Date: February 23, 2023
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Affected Products

Product: Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;

UDI/DI (01) 40888277986412; Lot numbers 22OBD978, exp. 1/31/2023; 22HBR887, exp. 12/31/2023; 22GBD420, exp. 12/31/2023; 22EBK277, exp. 12/31/2023; 22EBK012, exp. 9/30/2023; 22EBA934, exp. 1/31/2024; 22ABK594, exp. 4/30/2023; 21KBS545, exp. 6/30/2022; and 21JBL152, exp. 2/28/2023.

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Product: (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546D, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS.

(1) UDI/DI (01) 40889942055518; Lot numbers 21KBE911, exp. 3/31/2023; 21JBU806, exp. 3/31/2023; 21IBW034, exp. 3/31/2023; 21HBM415, exp. 3/31/2023; 21GBH194, exp. 3/31/2023; 21CBY712, exp. 3/31/2023; 21BBS824, exp. 3/31/2023; 21BBS043, exp. 3/31/2023; 20XBC895, exp. 12/31/2022; 20WBB357, exp. 8/31/2022; 20KBD323, exp. 9/30/2022; and 20JBT517, exp. 12/31/2021. (2) UDI/DI (01) 40195327069286; Lot number 22CBJ633, exp. 12/31/2022.

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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.

(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.

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91457
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Manufactured In: United States
Units Affected: 3 products (4,360 trays; 720 trays; 1,689 trays)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.