Microtek Patient Drape Adapter Kits Recalled for Non-Sterile Labeling
Microtek Medical recalls patient drape adapter kits labeled as sterile that are non-sterile, creating infection risk in medical procedures. The recall affects 2,024 boxes distributed across multiple U.S. states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with non-sterile products mislabeled as sterile creates infection risk in surgical settings. No illnesses or injuries have been reported, meeting the High (3) criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Microtek Medical, Inc. is recalling patient drape adapter plug kits (models AP6MMN and AP8MMN) because they are non-sterile but have been labeled and distributed as sterile products. These adapters are used in medical settings to connect surgical drape drain hoses to fluid management devices and reduce drain-hose opening size. The labeling error creates a risk of infection when non-sterile equipment is inadvertently used in procedures requiring sterile conditions.
The recall affects 2,024 boxes that were distributed to medical facilities in Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, North Carolina, New York, Ohio, Oregon, Tennessee, Texas, and Virginia. Specific lot numbers are identified for each adapter model (AP6MMN and AP8MMN).
Medical facilities that received these adapters should identify affected inventory by checking lot numbers against the recall notice, quarantine the products, and discontinue use. Facilities should contact Microtek Medical, Inc. for replacement sterile adapters or instructions on proper handling of the recalled inventory.
The recalled product
- 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
- Manufacturer
- Microtek Medical, Inc.
- Hazard
- sterility-mislabeling
- infection-risk
Distribution
Distributed in 20 states:
- AL
- AR
- CA
- CO
- CT
- FL
- GA
- IA
- IL
- IN
- KY
- MA
- MI
- NC
- NY
- OH
- OR
- TN
- TX
- VA
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