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Palmero Healthcare, LLC

Palmero Healthcare LLC · Model 60DIS · UDI-DI 00840415100007

LRJ
10
510(k) clearances
1,864
Adverse events (4 deaths)
17
Recalls
374
Facilities

Description

DISCIDE ULTRA 160ct TOWELETTES (160 C

Recalls

DateFirmReason
2026-06-30Medline Industries, LPMedline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.
2026-06-30Medline Industries, LPMedline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.
2026-06-30Medline Industries, LPMedline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.
2026-06-30Medline Industries, LPMedline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.
2023-12-20MEDLINE INDUSTRIES, LP - NorthfieldThere is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
2022-06-29MEDLINE INDUSTRIES, LP - Northfieldstability failure
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2021-12-29MEDLINE INDUSTRIES, LP - NorthfieldMicro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.