Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Ar

FDA device recall Z-2251-2023 · posted 2023-07-28 · Open, Classified

Recall details

Recalling firm

Microtek Medical Inc.

Reason for recall

Certain lots of the products have a Naphthalene odor.

Action taken

The recalling firm issued letters dated 6/15/2023 via email on 6/23/2023, unless they did not have an email address for the consignee, then those consignees were mailed a letter. The letter explained the reason for recall and requested the consignee immediately examine their inventory and quarantine the lots listed in the letter. The consignee is requested to dispose of product and packaging in accordance with hospital, administrative and/or local government policy and if unable to do so, they are instructed to call or email customer service to arrange for shipment of the affected product back to Ecolab. A response form was enclosed for return via email to report whether the consignee has affected product in their possession or not. The consignee is to indicate on the response form that they have read and understand the recall instructions, checked their stock and do not have any product to return, have checked their stock and are disposing of the listed inventory, or they have checked their stock and will send the listed inventory back to Ecolab. If the product was further distributed, the consignee is to identify and notify their customer at once of the product recall. A Distributor Response Form was also enclosed for completion. The Distributor Response Form is to report they have notified all customers that received the affected product and have provided their customers with a copy of the recall letter. The distributor is to report their customers' names, addresses, quantity of product shipped to the customer by SKU number and lot number, the amount the customer has available for disposal, and the date of disposal. The recall is being conducted to the user level.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KME

Quantity affected

9,293 cases/68,070 units for all products

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Date initiated

2023-06-23

Date posted

2023-07-28

Location

Saint Paul, MN