PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: June 18, 2025 Initiated: April 13, 2025 #Z-1963-2025

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.

Reason for Recall

Due to non-sterile products being labeled as sterile

Details

Recalling Firm
Microtek Medical, Inc.
Units Affected
2,024 boxes
Distribution
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
Location
Alpharetta, GA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Microtek Medical, Inc.. Units affected: 2,024 boxes.
Why was this product recalled?
Due to non-sterile products being labeled as sterile
Which agency issued this recall?
This recall was issued by the FDA Devices on June 18, 2025. Severity: Moderate. Recall number: Z-1963-2025.