11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
Check against the official notice below — it lists the full affected range.
Karl Storz has recalled certain Slim Nasopharyngolaryngoscope models (11001RD1 and 11001RDK1, model 96216006US V5.0) due to a failure to achieve the expected six-log reduction in microorganisms following the disinfection process. The affected devices include all serial numbers manufactured or distributed since January 2018 and were distributed nationwide in Florida, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, Oklahoma, South Carolina, Texas, and Washington.
The source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Reason for recall: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Distribution: U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA. Quantity: All Serial Numbers manufactured/distributed since January 2018 Lot/code info: 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018) UDI Code: 0408551225608 All Serial Numbers manufactured/distributed since January 2018
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.