MAXAIR CAPR
Received Apr 27, 2026 · Event occurred Apr 17, 2026
Report MW5187295 · MDR key 25000129
Device
Generic name
Gown, Surgical
Manufacturer
Syntech De Baja California, S De Rl De Cv.Model number
2180-05 FILTERLot number
1811008
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
A POTENTIAL EXPOSURE TO A TUBERCULOSIS PATIENT OCCURRED AFTER A STAFF MEMBER USED A MAXAIR CAPR FOR RESPIRATORY PROTECTION AND SUBSEQUENTLY LEARNED THAT THE FILTER IN THE CAPR HAD EXCEEDED THE MANUFACTURER'S RECOMMENDED SHELF LIFE. ON (B)(6) 2026, A NURSE WHO USED ONE OF THE MAXAIR CAPRS CONTACTED THE MANUFACTURER TO INQUIRE ABOUT THE SHELF LIFE OF THE FILTERS AS THERE IS NO EXPIRATION DATE CONTAINED ON THE PRODUCT LABEL. THE MANUFACTURER RESEARCHED THE LOT NUMBER OF THE FILTER AND DETERMINED THAT THE FILTER USED WAS MANUFACTURED IN 2020. INFECTION PREVENTION WAS CONSULTED AND DEEMED THE STAFF MEMBER WAS AT RISK OF TB EXPOSURE. PLEASE REQUEST THAT THE MANUFACTURER INCLUDE AN EXPIRATION DATE FOR PROPER SUPPLY MANAGEMENT/ROTATION TO ENSURE PRODUCTS ON THE SHELF CAN BE EASILY ASSESSED FOR EXPIRATION DATES. THE MANUFACTURER STATES FILTERS HAVE A SHELF LIFE OF 5 YEARS HOWEVER THE PRODUCT LABEL ON THE FILTERS DOES NOT CONTAIN AN EXPIRATION DATE OR A MANUFACTURING DATE. THE MANUFACTURER DOES NOT PROVIDE EFFICACY DATA ON FILTERS USED BEYOND THE 5 YEAR SHELF LIFE.