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.
FDA Recall Z-1963-2025 · Posted 2025-06-12
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Recalling FirmMicrotek Medical, Inc.
Recall StatusOpen, Classified
Product CodePUI
Date Initiated2025-04-13
Product Quantity2,024 boxes
Reason for Recall
Due to non-sterile products being labeled as sterile
Firm 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 affected product in your possession, please dispose of the product and packaging in according to your hospital, administrative and /or local government policy. If you are unable to dispose of the product, please send the product back to:
Medline / Microtek Medical LLC.
13500 Tradeport Circle E
Jacksonville, FL, 32218 USA
For questions/assistance - contact Customer Service at 1-800-633-5463 (Medline).
The firm is planning on communicating an updated letter in the near future.
Root Cause
Labeling Change Control
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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