Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.
Distributed: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Distributed: Worldwide - US Nationwide distribution.Reason: The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.
Distributed: Worldwide distribution - US Nationwide and the country of Canada.Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.
Distributed: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.
Distributed: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Distributed: Worldwide - Nationwide and the country of Canada.Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.
Distributed: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Reason: An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
Distributed: U.S.: CA O.U.S.: N/AReason: Product may be potentially contaminated with a lubricant used during the manufacturing process.
Distributed: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Distributed: Worldwide - Nationwide and the country of Canada.