Device product
TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567
Z-2206-2018
Product summary
- Event
- Event 80169
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 box
- Official record key
device-enforcement:Z-2206-2018
Official wording
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Code information: UPN: H96560M1405671; Lot: 5316349
Distribution pattern: The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
Derived failure modes
-
Unknown
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).