Recall Z-1963-2025 ยท PUI Drape, Surgical, Exempt
Microtek Medical, Inc.
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
| Date | Jun 12, 2025 (initiated Apr 13, 2025) |
| Status | Open, Classified |
| Reason | Due to non-sterile products being labeled as sterile |
| Root cause | Labeling Change Control |
| Action | On 04/13/2025, the firm sent via FedEx a Customer Notification Letter to customers informing them there was a label error on products AP6MMN and AP8MMN where the products that were not designed or intended to be sterile and have not gone through any sterilization were labeled as sterile. Customer are instructed to: immediately examine your inventory for the lots listed in Attachment A and remove all products from your inventory regardless of its location and segregate this product in a secure location. The lot number can be found on the individual package or case label. If you have an affecte |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.