Recall Z-2332-2018— ECOLAB INC
Class III · Terminated
Class III FDA medical device recall by ECOLAB INC, initiated 2017-11-22, terminated 2020-07-22. It names one FDA 510(k) clearance: K961029. Product: ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, 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: The incorrect IFU was shipped with the product..
- Recalling firm
- ECOLAB INC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-11-22
- Terminated
- 2020-07-22
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.