Recall Z-1963-2025— Microtek Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Microtek Medical, Inc., initiated 2025-04-13. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Due to non-sterile products being labeled as sterile.
- Recalling firm
- Microtek Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-13
- Firm location
- Alpharetta, GA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.