Z-2333-2018 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 11, 2018
- Initiation Date
- November 22, 2017
- Termination Date
- July 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 cases
Product Description
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).
Reason for Recall
The incorrect IFU was shipped with the product.
Distribution Pattern
US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
Code Information
Lot numbers D152291, D160961, D161161, D161311, D161371, and D161721.