Recall Z-1180-2024— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-12-20. FDA's recall record names no specific 510(k) clearance for this event. 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). Reason: There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-20
- Firm location
- Northfield, IL, United States
Product description
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)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.