RecallDepth

These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal activites. MEDLINE MICRO-KILL Bleach GERMICIDAL BLEACH WIPES: a) MSC351400AN/Z (7 X 8 , 150 ct canister), b) MSC351410AN/Z (6 x 5 , 150ct canister), c) MSC3560012 (private-labeled 6 x 5 , 150ct canister), d) MSC351450AN (12" x 12", 110ct bucket), e) MSC351450BG4 (12" x 12", 110ct bag)

This recall is currently active, issued February 22, 2024. It was issued by Medline Industries, Lp - Northfield.

Company
Medline Industries, Lp - Northfield
Recall Initiated
December 20, 2023
Posted
February 22, 2024
Recall Number
Z-1180-2024
Quantity
1,314,719 units
Firm Location
Northfield, IL
Official Source
View on FDA website ↗

Reason for Recall

There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.

Distribution

US and territories, S. Korea, Panama, and Dubai

Lot / Code Info

a) MSC351400AN, UDI/DI 10888277652514, Lot Numbers: 012422C, 012422C2, 020822C, 022422C, 022622C, 030522C, 032522C, 032922C, 033022C, 033122C, 040422C, 042822C, 050622C, 052022C4, 061722C, 080222C2, 090622C, 100222C, 102722C2, 102822C, 110422C, 110422C2, 110722C, 120222C, 120322C, 120722C, 122222C, 122822C, 011123C, 011323C, 011923C, 011923C2, 012523C, 012623C, 030823C, 030923C, 040423C, 042823C, 050923C, 051223C, 051723C, 060723V, 060923C, 061023C, 061023C2, 081123C, 081423C, 081823C, 082823C, 091423C, 102323C, 102423C, 111323C, 111423C; b) MSC351410AN, UDI/DI 10888277652521, Lot Numbers: 012522C, 020322C, 020622C, 020522C, 021122C2, 021222C, 021822C, 022722C, 022822C, 030222C, 030322C, 030822C, 030922C, 032922C, 042222C, 052022C3, 061722C2, 080222C, 090922C2, 102622C, 102722C, 102822C, 120122C, 120522C, 120622C, 122322C2, 122822C2, 010323C, 010523C, 030323C, 030723C, 032823C, 050323C, 050323C2, 051923C, 061223C, 061523C, 061923C, 062022C2, 062323C, 080323C, 082323C, 082423C, 082523C, 101223C, 103023C, 111423C, 111523C, 111623C; c) MSC351450AN, UDI/DI 80080196314521, Lot Numbers: 090922B, 033023V, 060723V; d) MSC3560012, UDI/DI 847713000350, Lot Numbers: 102022C, 102122C, 102122C2, 102422C, 102522C, 021523C, 021623C, 022023C, 022223C, 040423C, 041023C, 041223C, 102423C2, 102623C2, 102723C2; e) MSC351450BG4, UDI/DI 00193489015242, Lot Numbers: 090922B, 033023V, 060723V

Root Cause

Process control

Action Taken

Medline Industries, LP issued an IMMEDIATE ACTION REQUIRED notice to it consignees on 12/20/2023 via USPS first class mail. The notice explained the problem with the device and requested that the consignee destroy all affected product. Any parties to whom the product was transferred must be notified of the recall communication. For questions, please contact 866-359-1704.

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