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Class 2 Device Recall MEDLINE |
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| Date Initiated by Firm |
December 20, 2023 |
| Date Posted |
February 22, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1180-2024 |
| Recall Event ID |
93745 |
| Product Classification |
Disinfectant, medical devices - Product Code LRJ
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| Product |
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) |
| Code Information |
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
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact |
Karin Johnson
886-359-1704
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Manufacturer 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.
|
FDA Determined
Cause 2 |
Process control |
| Action |
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. |
| Quantity in Commerce |
1,314,719 units |
| Distribution |
US and territories, S. Korea, Panama, and Dubai |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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