Device product
ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).
Z-2333-2018
Product summary
- Firm
- ECOLAB INC
- Event
- Event 80160
- Status
- Terminated
- Classification
- Class III
- Quantity
- 65 cases
- Official record key
device-enforcement:Z-2333-2018
Official wording
Reason: The incorrect IFU was shipped with the product.
Code information: Lot numbers D152291, D160961, D161161, D161311, D161371, and D161721.
Distribution pattern: US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
Derived failure modes
-
Unknown
The incorrect IFU was shipped with the product.