ClearanceBrief
Recall Z-0696-2022 ยท LRJ Disinfectant, Medical Devices

MEDLINE INDUSTRIES, LP - Northfield

MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes

DateMar 1, 2022 (initiated Dec 29, 2021)
StatusOpen, Classified
ReasonMicro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.
Root causeUnder Investigation by firm
ActionThe firm initiated the recall on January 13, 2022 and provided each consignee with a letter and a response form to record their response to the recall notification. Each response received will be recorded and the firm will send subsequent letters to consignees that have not provided a response to the recall notification in the allotted time. The letter explained the issue and requested return of the product, if available. Customers will be responsible for initiating sub-recall procedures. Any recalled product that is returned from customers will be quarantined at the firm's corporate office pe
Quantity359,524 units
DistributionWorldwide distribution - US Nationwide and the countries of Panama and Bermuda.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.