MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes

FDA device recall Z-0696-2022 · posted 2022-03-01 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.

Action taken

The 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 pending destruction. The firm expanded the original recall notification dated January 13, 2022 to include additional lots of the Micro-Kill Bleach Germicidal Bleach Wipes due to product not meeting label claim for Sodium Hypochlorite content. A letter was sent out to all consignees within the scope of the expanded recall on 02/25/2022 with the same instructions. The firm sent a letter dated July 27, 2022, to previous non-responding consignees instructing them to destroy any affected product per their local and state regulations and document the destruction.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LRJ

Quantity affected

359,524 units

Distribution

Worldwide distribution - US Nationwide and the countries of Panama and Bermuda.

Date initiated

2021-12-29

Date posted

2022-03-01

Location

Northfield, IL