Device product
Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00038) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Bifurcated Outflow Patient Line (P/N 902-00040P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).
Z-1676-2025
Product summary
- Event
- Event 96617
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 136 sets
- Official record key
device-enforcement:Z-1676-2025
Official wording
Reason: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Code information: Model Number: 902-00038. UDI-DI: 00896128002220. Lot Number: 20241013
Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, Malaysia.
Derived failure modes
-
Unknown
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.