Device product
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Z-2494-2018
Product summary
- Event
- Event 80288
- Status
- Terminated
- Classification
- Class II
- Quantity
- A total of 63,020 valves were distributed. Specific product quantities were not provided.
- Official record key
device-enforcement:Z-2494-2018
Official wording
Reason: The suction valve may not close properly which could cause continuous suction.
Code information: Lot numbers 71725, 81743, 91722, and 101723.
Distribution pattern: Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.
Derived failure modes
-
Unknown
The suction valve may not close properly which could cause continuous suction.