Microtek Medical, Inc.: Device Recall

Recall Details

Recall Number

Z-1963-2025

Classification

Class II

Product Type

Device

Recalling Firm

Microtek Medical, Inc.

Status

Ongoing

Date Initiated

04/13/2025

Location

Alpharetta, GA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

2,024 boxes

Reason for Recall

Due to non-sterile products being labeled as sterile

Product Description

Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size.

Distribution Pattern

U.S.: AL. AR, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, NC, NY, OH, OR, TN, TX, and VA O.U.S.: N/A

Other Recalls by Microtek Medical, Inc.

• Class II: Risk 06/03/2024
  During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
• Class II: Risk 06/03/2024
  During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
• Class II: Risk 06/03/2024
  During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
• Class II: Risk 06/03/2024
  During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
• Class II: Risk 06/03/2024
  During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

View all recalls by Microtek Medical, Inc. →